What side effects are associated with this type of intervention?

Common treatments for retinal detachment include surgical procedures such as pars plana vitrectomy, often accompanied by the use of corticosteroids like subtenon triamcinolone acetonide to reduce inflammation. Known side effects of corticosteroid use in this context can include a transient rise in intraocular pressure, which may require monitoring and management. Other potential side effects, although less common, can include cataract formation and increased risk of infection. Overall, these treatments are generally considered safe and effective when appropriately managed.

What prior FDA approvals exist?

The FDA has approved various treatments for retinal detachment, including surgical interventions like vitrectomy and pneumatic retinopexy. While specific FDA approvals for corticosteroids like subtenon triamcinolone acetonide in the context of retinal detachment are not detailed, corticosteroids are commonly used to reduce inflammation post-surgery. Subtenon triamcinolone acetonide is being studied for its potential to eliminate the need for postoperative eye drops, indicating its role in managing inflammation and improving surgical outcomes.

What other types of research exist?

Promising novel alternatives to Subtenon Triamcinolone Acetonide for Retinal Detachment patients include anti-VEGF (vascular endothelial growth factor) therapies such as Ranibizumab and Aflibercept, which are being explored for their anti-inflammatory and anti-fibrotic properties. Additionally, sustained-release corticosteroid implants like Dexamethasone intravitreal implants (Ozurdex) offer a longer duration of action and targeted delivery, potentially improving patient outcomes.

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Steroid During Surgery vs Eye Drops After Surgery for Retinal Detachment (DVS Trial)

Phase 4

Recruiting

Led By Nimesh A. Patel, MD

Research Sponsored by Massachusetts Eye and Ear Infirmary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Primary rhegmatogenous retinal detachment (mac-on or mac-off) requiring pars plana vitrectomy (23, 25 and 27-gauge)

Be older than 18 years old

Must not have

Diagnosis of proliferative diabetic retinopathy

Individuals with impaired decision-making capacity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, 7, 30 and 90 after surgical procedure

Awards & highlights

All Individual Drugs Already Approved

Approved for 20 Other Conditions

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial is testing if a steroid injection around the eye during surgery can replace the usual post-surgery eye drops for patients with a specific type of retinal detachment. The injection aims to reduce swelling and inflammation. Steroid injections around the eye have been used to control inflammation and pain after eye surgeries, offering prolonged drug activity at the target tissue.

Who is the study for?

This trial is for individuals with a primary type of retinal detachment who need surgery and can start treatment within seven days of diagnosis. It's not for those with prior eye surgeries (except laser), glaucoma, giant tears, or certain eye conditions like infections or inflammations.

What is being tested?

The study tests if using triamcinolone acetonide during surgery is as good as post-surgery eye drops in treating retinal detachment. Patients won't use post-op drops but will receive other standard medications and undergo pars plana vitrectomy.

What are the potential side effects?

Possible side effects include increased pressure inside the eye, allergic reactions to the drugs used, temporary vision changes, discomfort or redness in the eye area, and a risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need surgery for a specific type of retinal detachment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with an advanced stage of diabetic eye disease.

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I am unable to make decisions for myself.

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I cannot use or apply eye drops.

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I do not speak English.

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I have inflammation in the front part of my eye.

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I have had a retinal detachment in the eye that will be operated on.

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I have glaucoma or my eye pressure is above 21 mmHg.

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I have responded well to steroid treatments in the past.

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I am currently using corticosteroids in a pill, cream, or eye injection form.

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I have had eye surgery before, but not laser surgery.

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I have been diagnosed with a complex retinal disease.

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I have or had chronic eye inflammation.

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I have signs of an eye infection.

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I need surgery for cataract or lens removal.

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I was diagnosed with a giant tear in my retina.

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I have an active eye infection.

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I do not have any uncontrolled eye or systemic diseases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, 7, 30 and 90 after surgical procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, 7, 30 and 90 after surgical procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, 7, 30 and 90 after surgical procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Adverse events

Degree of pain

Intraocular pressure less than 5 or more 30 mmHg

+7 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Group 2Active Control2 Interventions

* Subtenon triamcinolone acetonide (40 mg/1mLl) at the time of surgery * Subconjunctival antibiotic (cefazolin 50 mg/0.5 mL, moxifloxacin 0.5 mg/0.1 mL, or vancomycin 1 mg/0.1 mL) and subconjunctival dexamethasone (4 mg/mL) at the time of surgery * Topical atropine 1% and antibiotic-steroid ointment (neomycin-polymyxin B-dexamethasone) at the time of surgery * No postoperative eye drops

Group II: Group 1Active Control4 Interventions

* Subconjunctival antibiotic (cefazolin 50 mg/0.5 mL, moxifloxacin 0.5 mg/0.1 mL, or vancomycin 1 mg/0.1 mL) and subconjunctival dexamethasone (4 mg/mL) at the time of surgery * Topical atropine 1% and antibiotic-steroid ointment (neomycin-polymyxin B-dexamethasone) at the time of surgery * Topical moxifloxacin 0.5% or Polymyxin/Trimethoprim if patient is allergic to moxifloxacin; 4 times per day for 1 week after surgery. * Topical prednisolone 1% 1 drop 4 times per day tapered by one drop weekly for 4 weeks (4/3/2/1 taper) * Topical atropine 1% daily for 1 week

0 / 18Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for retinal detachment include corticosteroids like subtenon triamcinolone acetonide, which reduce inflammation and edema, aiding in the stabilization of the retina post-surgery. Other treatments such as pneumatic retinopexy, scleral buckling, and vitrectomy work by reattaching the retina through different mechanisms: creating a gas bubble to push the retina back, indenting the eye wall to relieve traction, or removing the vitreous gel pulling on the retina. These treatments are essential for restoring vision and preventing further retinal damage, making it important for patients to understand how they function.

Intravitreal triamcinolone for diabetic macular edema that persists after laser treatment: three-month efficacy and safety results of a prospective, randomized, double-masked, placebo-controlled clinical trial.