Retisert

Otitis Externa, Uveitis, Perianal erythema + 30 more
Treatment
3 FDA approvals
20 Active Studies for Retisert

What is Retisert

Fluocinolone acetonideThe Generic name of this drug
Treatment SummaryFluocinolone acetonide is a type of corticosteroid that is used in dermatological treatments and to make implantable corticosteroid devices. These devices are made by Taro Pharmaceuticals and have been approved by the FDA since 2016. The formula 6-alpha, 9-alpha-difluoro-16-alpha, 17 alpha-acetonide makes this drug highly lipophilic, or able to dissolve in fat.
Neo-Synalaris the brand name
Retisert Overview & Background
Brand Name
Generic Name
First FDA Approval
How many FDA approvals?
Neo-Synalar
Fluocinolone acetonide
1963
93

Approved as Treatment by the FDA

Fluocinolone acetonide, otherwise called Neo-Synalar, is approved by the FDA for 3 uses like Chronic Uveitis and Uveitis .
Chronic Uveitis
Uveitis
Uveitis

Effectiveness

How Retisert Affects PatientsFluocinolone acetonide is a medication used to reduce inflammation. It comes in a form that can be injected directly into the eye, and has been shown to reduce the recurrence of uveitis flares by two times compared to patients not taking it. However, this medication can cause a slight increase in eye pressure, so it is important to monitor your pressure closely.
How Retisert works in the bodyFluocinolone acetonide is a steroid that reduces inflammation in the body. It works by binding to glucocorticoid receptors in the cell nucleus, which then triggers the production of proteins called lipocortins. These lipocortins stop the release of arachidonic acid, which is the precursor to inflammation-causing substances like prostaglandins and leukotrienes. This process reduces inflammation and prevents further damage.

When to interrupt dosage

The recommended dosage of Retisert is contingent upon the determined condition, including Hemorrhoids, Perianal erythema and Itch. The amount of dosage is contingent upon the method of administration (e.g. Kit or Emulsion - Topical) featured in the table below.
Condition
Dosage
Administration
postoperative treatment
, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg
Topical, , Cream, Cream - Topical, Solution, Solution - Topical, Ointment, Ointment - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Intravitreal, Implant - Intravitreal, Implant, Shampoo - Topical, Shampoo, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Gel, Emulsion, Emulsion - Topical, Intraocular, Implant - Intraocular
Skin Inflammation caused by Bacterial Infections
, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg
Topical, , Cream, Cream - Topical, Solution, Solution - Topical, Ointment, Ointment - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Intravitreal, Implant - Intravitreal, Implant, Shampoo - Topical, Shampoo, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Gel, Emulsion, Emulsion - Topical, Intraocular, Implant - Intraocular
Uveitis
, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg
Topical, , Cream, Cream - Topical, Solution, Solution - Topical, Ointment, Ointment - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Intravitreal, Implant - Intravitreal, Implant, Shampoo - Topical, Shampoo, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Gel, Emulsion, Emulsion - Topical, Intraocular, Implant - Intraocular
Otitis Media
, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg
Topical, , Cream, Cream - Topical, Solution, Solution - Topical, Ointment, Ointment - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Intravitreal, Implant - Intravitreal, Implant, Shampoo - Topical, Shampoo, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Gel, Emulsion, Emulsion - Topical, Intraocular, Implant - Intraocular
Eczema
, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg
Topical, , Cream, Cream - Topical, Solution, Solution - Topical, Ointment, Ointment - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Intravitreal, Implant - Intravitreal, Implant, Shampoo - Topical, Shampoo, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Gel, Emulsion, Emulsion - Topical, Intraocular, Implant - Intraocular
Pressure Ulcer
, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg
Topical, , Cream, Cream - Topical, Solution, Solution - Topical, Ointment, Ointment - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Intravitreal, Implant - Intravitreal, Implant, Shampoo - Topical, Shampoo, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Gel, Emulsion, Emulsion - Topical, Intraocular, Implant - Intraocular
Skin
, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg
Topical, , Cream, Cream - Topical, Solution, Solution - Topical, Ointment, Ointment - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Intravitreal, Implant - Intravitreal, Implant, Shampoo - Topical, Shampoo, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Gel, Emulsion, Emulsion - Topical, Intraocular, Implant - Intraocular
Postoperative Care
, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg
Topical, , Cream, Cream - Topical, Solution, Solution - Topical, Ointment, Ointment - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Intravitreal, Implant - Intravitreal, Implant, Shampoo - Topical, Shampoo, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Gel, Emulsion, Emulsion - Topical, Intraocular, Implant - Intraocular
Surgery; Ear
, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg
Topical, , Cream, Cream - Topical, Solution, Solution - Topical, Ointment, Ointment - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Intravitreal, Implant - Intravitreal, Implant, Shampoo - Topical, Shampoo, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Gel, Emulsion, Emulsion - Topical, Intraocular, Implant - Intraocular
Conjunctivitis, Bacterial
, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg
Topical, , Cream, Cream - Topical, Solution, Solution - Topical, Ointment, Ointment - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Intravitreal, Implant - Intravitreal, Implant, Shampoo - Topical, Shampoo, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Gel, Emulsion, Emulsion - Topical, Intraocular, Implant - Intraocular
Ear structure
, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg
Topical, , Cream, Cream - Topical, Solution, Solution - Topical, Ointment, Ointment - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Intravitreal, Implant - Intravitreal, Implant, Shampoo - Topical, Shampoo, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Gel, Emulsion, Emulsion - Topical, Intraocular, Implant - Intraocular
Otitis Externa
, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg
Topical, , Cream, Cream - Topical, Solution, Solution - Topical, Ointment, Ointment - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Intravitreal, Implant - Intravitreal, Implant, Shampoo - Topical, Shampoo, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Gel, Emulsion, Emulsion - Topical, Intraocular, Implant - Intraocular
Uveitis
, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg
Topical, , Cream, Cream - Topical, Solution, Solution - Topical, Ointment, Ointment - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Intravitreal, Implant - Intravitreal, Implant, Shampoo - Topical, Shampoo, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Gel, Emulsion, Emulsion - Topical, Intraocular, Implant - Intraocular
Wound Infection
, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg
Topical, , Cream, Cream - Topical, Solution, Solution - Topical, Ointment, Ointment - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Intravitreal, Implant - Intravitreal, Implant, Shampoo - Topical, Shampoo, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Gel, Emulsion, Emulsion - Topical, Intraocular, Implant - Intraocular
Perianal erythema
, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg
Topical, , Cream, Cream - Topical, Solution, Solution - Topical, Ointment, Ointment - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Intravitreal, Implant - Intravitreal, Implant, Shampoo - Topical, Shampoo, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Gel, Emulsion, Emulsion - Topical, Intraocular, Implant - Intraocular
Scab
, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg
Topical, , Cream, Cream - Topical, Solution, Solution - Topical, Ointment, Ointment - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Intravitreal, Implant - Intravitreal, Implant, Shampoo - Topical, Shampoo, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Gel, Emulsion, Emulsion - Topical, Intraocular, Implant - Intraocular
Itching
, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg
Topical, , Cream, Cream - Topical, Solution, Solution - Topical, Ointment, Ointment - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Intravitreal, Implant - Intravitreal, Implant, Shampoo - Topical, Shampoo, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Gel, Emulsion, Emulsion - Topical, Intraocular, Implant - Intraocular
Psoriasis of the scalp
, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg
Topical, , Cream, Cream - Topical, Solution, Solution - Topical, Ointment, Ointment - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Intravitreal, Implant - Intravitreal, Implant, Shampoo - Topical, Shampoo, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Gel, Emulsion, Emulsion - Topical, Intraocular, Implant - Intraocular
Skin Diseases
, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg
Topical, , Cream, Cream - Topical, Solution, Solution - Topical, Ointment, Ointment - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Intravitreal, Implant - Intravitreal, Implant, Shampoo - Topical, Shampoo, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Gel, Emulsion, Emulsion - Topical, Intraocular, Implant - Intraocular
Dermatitis, Seborrheic
, 0.0001 mg/mg, 0.1 mg/mL, 0.00025 mg/mg, 0.11 mg/mL, 0.011 mg/mL, 0.0011 mg/mL, 0.01 %, 0.59 mg, 0.025 %, 0.19 mg, 0.0001 mg/mL, 0.25 mg/mL, 1.0 mg/mg, 0.18 mg, 0.625 mg/mL, 0.000003 mg/mg
Topical, , Cream, Cream - Topical, Solution, Solution - Topical, Ointment, Ointment - Topical, Kit, Oil, Auricular (otic), Oil - Auricular (otic), Oil - Topical, Kit - Topical, Solution - Auricular (otic), Intravitreal, Implant - Intravitreal, Implant, Shampoo - Topical, Shampoo, Solution / drops, Solution / drops - Auricular (otic), Gel - Topical, Gel, Emulsion, Emulsion - Topical, Intraocular, Implant - Intraocular

Warnings

Retisert has four prohibitions and should not be taken in combination with the ailments listed in the table below.Retisert Contraindications
Condition
Risk Level
Notes
Severe Hypersensitivity Reactions
Do Not Combine
Fluocinolone Acetonide may interact with conjunctiva
Mycoses
Do Not Combine
External auditory canal structure
Do Not Combine
Severe Hypersensitivity Reactions
Do Not Combine
Fluocinolone Acetonide may interact with conjunctiva
There are 20 known major drug interactions with Retisert.
Common Retisert Drug Interactions
Drug Name
Risk Level
Description
2-Methoxyethanol
Major
The risk or severity of adverse effects can be increased when Fluocinolone acetonide is combined with 2-Methoxyethanol.
9-(N-methyl-L-isoleucine)-cyclosporin A
Major
The risk or severity of adverse effects can be increased when Fluocinolone acetonide is combined with 9-(N-methyl-L-isoleucine)-cyclosporin A.
Abatacept
Major
The risk or severity of adverse effects can be increased when Fluocinolone acetonide is combined with Abatacept.
Abemaciclib
Major
The metabolism of Abemaciclib can be increased when combined with Fluocinolone acetonide.
Abetimus
Major
The risk or severity of adverse effects can be increased when Fluocinolone acetonide is combined with Abetimus.
Retisert Toxicity & Overdose RiskStudies have not been conducted to determine the cancer-causing effects or the impact on fertility of taking fluocinolone acetonide. However, other corticosteroids have been shown to cause genetic damage, but tests have found that fluocinolone acetonide does not cause genetic damage.

Retisert Novel Uses: Which Conditions Have a Clinical Trial Featuring Retisert?

97 active clinical trials are currently being conducted to assess the utility of Retisert in alleviating Atopic Dermatitis, Otitis Media and Otitis Externa.
Condition
Clinical Trials
Trial Phases
Hemorrhoids
1 Actively Recruiting
Not Applicable
Perianal erythema
0 Actively Recruiting
Eczema
0 Actively Recruiting
Blister
0 Actively Recruiting
Otitis Externa
0 Actively Recruiting
Psoriasis of the scalp
1 Actively Recruiting
Phase 4
Otitis
3 Actively Recruiting
Not Applicable
Hemorrhoids
0 Actively Recruiting
Scab
0 Actively Recruiting
Ear structure
0 Actively Recruiting
Skin
0 Actively Recruiting
Skin Diseases
0 Actively Recruiting
Fissure in Ano
0 Actively Recruiting
Postoperative Care
5 Actively Recruiting
Early Phase 1, Phase 4, Not Applicable
Wound Infection
0 Actively Recruiting
Skin Inflammation caused by Bacterial Infections
0 Actively Recruiting
Uveitis
3 Actively Recruiting
Not Applicable, Phase 3
Conjunctivitis, Bacterial
0 Actively Recruiting
Coinfection
0 Actively Recruiting
Chronic disease
0 Actively Recruiting

Patient Q&A Section about retisert

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does RETISERT work?

"The Retisert implant is a corticosteroid used to treat inflammation within the eye that may be caused by a variety of diseases or infections. The Retisert implant slowly releases the drug into the eye over a period of approximately 30 months. However, Retisert will not treat an eye infection."

Answered by AI

Who makes retisert?

"Two or more intraocular injections of 0.1 mL (8 mcg) of RETISERT [bimatoprost (r-prostaglandin F2 alpha)] were given 91 to 180 days apart in the study eye of 22 uveitis patients.

In a study of 22 uveitis patients, two or more intraocular injections of 0.1 mL (8 mcg) of RETISERT [bimatoprost (r-prostaglandin F2 alpha)] were given 91 to 180 days apart in the study eye."

Answered by AI

What is Yutiq?

"The YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18 mg is a medical device that is used to treat chronic non-infectious uveitis affecting the back of the eye."

Answered by AI

Clinical Trials for Retisert

Image of University of California, Los Angeles in Los Angeles, United States.

Hemorrhoidal Artery Embolization for Hemorrhoids

18 - 90
All Sexes
Los Angeles, CA
Hemorrhoidal artery embolization (HAE) is a novel treatment for symptomatic internal hemorrhoids. HAE involves the deliberate blockage (embolization) of enlarged rectal or hemorrhoidal arteries leading to reduction of abnormal blood flow to the hemorrhoidal tissue. The aim of HAE is to the improve hemorrhoid related symptoms, especially bleeding. Initial reports of HAE have demonstrated that it both safe and effective. Following an initial clinic visit to determine trial candidacy, enrolled patients will be subsequently treated with HAE. Patients will be followed for a year with clinic follow-up visits at 1, 3, 6 and 12 months.
Recruiting
Has No Placebo
University of California, Los AngelesLucas Cusumano, MD
Have you considered Retisert clinical trials? We made a collection of clinical trials featuring Retisert, we think they might fit your search criteria.Go to Trials
Image of Women and Infants Hospital in Providence, United States.

Postoperative Care for Minimally Invasive Gynecologic Surgery

18+
Female
Providence, RI
The goal of this randomized controlled trial is to assess recovery in patients undergoing benign laparoscopic gynecologic surgery. The main question it aims to answer is: do liberalized postoperative restrictions improve patient recovery after laparoscopic gynecologic surgery? Researchers will compare postoperative recovery surveys from the control group (patients given standard postoperative restrictions limiting activity for 2 weeks) to the research group (patients given liberalized postoperative instructions allowing them to engage in their normal activities of daily life at their own discretion without prescribed activity restrictions) to see if liberalized postoperative restrictions improve the recovery experience. Participants will be asked to fill out a brief questionnaire at two time intervals, 1 week after surgery and 2 weeks after surgery.
Waitlist Available
Has No Placebo
Women and Infants HospitalChristine Foley, MD
Image of The University of Alabama at Birmingham in Birmingham, United States.

Octreotide for Diabetic Macular Edema

18 - 90
All Sexes
Birmingham, AL
Treatment of diabetic retinopathy (DR) and diabetic macula edema has included panretinal photocoagulation and intra ocular injections of anti-vascular endothelial growth factors (anti-VEGF) agents and steroids. Anti-VEGF therapy is currently the first-line treatment for proliferative diabetic retinopathies; however, this approach is ineffective in more than 30% of patients with diabetic retinal complications. Available evidence shows that subcutaneous (under the skin) injection of octreotide, a somatostatin analog, has potential therapeutic benefits in proliferative diabetic retinopathy (PDR) and diabetic macula edema (DME). This study thus seeks to determine the efficacy and safety of intranasal DDM-octreotide in the treatment of diabetic macula edema in individuals that are considered to be refractory to the current therapeutic options.
Phase 1
Waitlist Available
The University of Alabama at BirminghamMaria Grant, MD, FARVO
Image of Associated Retinal Consultants PC in Phoenix, United States.

RO7446603 + Aflibercept/Faricimab for Diabetic Macular Edema

18+
All Sexes
Phoenix, AZ
This study aims to evaluate the ocular and systemic safety, tolerability and efficacy of RO7446603 in participants with diabetic macular edema (DME). The study consists of 2 segments: Phase I (Parts 1-4) and Phase II (Part 5). Phase I investigated the safety of RO7446603 following a single and multiple intravitreal (IVT) doses as monotherapy or co-administered with IVT aflibercept or IVT faricimab (in separate injections). Phase II will investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of two dose levels of RO7446603 in combination with faricimab, with the two drugs co-mixed and administered as a single IVT injection, compared to faricimab alone. The first participant was enrolled in the Phase I segment on June 22, 2022. Phase I has been completed.
Phase 1 & 2
Recruiting
Associated Retinal Consultants PC (+66 Sites)Clinical TrialsGenentech, Inc.
Image of Retinal Consultants of AZ, Ltd in Peoria, United States.

RO7497372 for Diabetic Macular Edema

18+
All Sexes
Peoria, AZ
This study will assess the safety and tolerability of RO7497372 in participants with DME. The study consists of 2 parts. Part 1 will test multiple-ascending doses of RO7497372 after unilateral intravitreal (IVT) administration in participants with DME. The main purpose of Part 1 is to provide data for RO7497372 safety and tolerability, as well as to characterize the ocular and systemic pharmacokinetics (PK), systemic anti-drug antibodies (ADA), and duration of target engagement, i.e., the pharmacodynamics (PD) in aqueous humor (AH) and blood. Part 2 will evaluate the safety, tolerability, PK, and PD of two dose strengths of RO7497372 (low dose and high dose), identified as safe and tolerated in Part 1.
Phase 1
Recruiting
Retinal Consultants of AZ, Ltd (+32 Sites)Clinical TrialsGenentech, Inc.
Have you considered Retisert clinical trials? We made a collection of clinical trials featuring Retisert, we think they might fit your search criteria.Go to Trials
Image of University of Virginia in Charlottesville, United States.

Methadone vs Remifentanil for Pain in Craniotomy Surgery

18 - 65
All Sexes
Charlottesville, VA
Postoperative pain is prevalent after intracranial surgery. Patients undergoing craniotomy are typically managed with short acting opioids to enable early and reliable post-operative neurological exam as well as avoid the risk of respiratory depression. However, a plethora of studies have shown that a majority of these patients experience moderate to severe pain in first 48 hours after surgery. Suboptimal pain control can lead to complications such as arterial hypertension and post-operative intracranial hemorrhage, and hence, increased morbidity and mortality. Intravenous (IV) methadone has a long analgesic half-life and has N-methyl-D-aspartate (NMDA) receptor antagonist and serotonin and norepinephrine reuptake inhibitor (SNRI) properties. It has previously been shown to reduce postoperative opioid requirements, postoperative nausea and vomiting (PONV), and postoperative pain scores in patients that underwent orthopedic, abdominal, complex spine, and cardiac surgery. Similar findings have been shown in obstetric patients that underwent caesarean delivery under general anesthesia as well as patients that underwent gynecologic surgery and received IV methadone intraoperatively. In a recently published retrospective study, a single intraoperative dose of IV methadone was well tolerated with lower pain scores as well as MME (oral morphine milligram equivalents) requirements for up to 72 hours after elective intracranial surgery. IV methadone has, however, never been compared with conventional management via IV remifentanil for functional recovery in patients undergoing elective intercranial surgery. The investigator's hypothesis is that intravenous (IV) methadone is non-inferior to IV remifentanil in patients who undergo elective intracranial surgery. It offers the advantage of being a single dose noninvasive analgesic modality that may contribute to decreasing MME consumption during the first 72 hours postoperatively, controlling postoperative pain, and improving quality of recovery after surgery.
Phase < 1
Waitlist Available
University of Virginia
Image of Scottsdale, Arizona in Scottsdale, United States.

EYE201 for Eye Conditions

18+
All Sexes
Scottsdale, AZ
EYE-TIE-201 is a 2-part study to investigate the safety and effectiveness of a new drug being developed called EYE201. All participants in the study will receive a total of 3 injections of EYE201 into the study eye, spaced at 4 weeks apart. In the first part, termed the multiple ascending dose (MAD) portion of study, the safety of EYE201 will be assessed at increasing doses in branch retinal vein occlusion (BRVO) participants. Approximately 12 participants will be entered in this part of the study. In the second part of the study, called the dose finding part, 2 doses of EYE201 will be selected and their effectiveness will be compared. This portion of the study assesses the safety and preliminary efficacy of EYE201 in patients with diabetic macular edema (DME) or neovascular macular degeneration (NVAMD). Approximately 80 participants will be entered in this part of the study.
Phase 1 & 2
Recruiting
Scottsdale, Arizona (+25 Sites)EyeBiotech Ltd.
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