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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 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

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.

Find a Location

Who is running the clinical trial?

Massachusetts Eye and Ear InfirmaryLead Sponsor
108 Previous Clinical Trials
12,866 Total Patients Enrolled
2 Trials studying Retinal Detachment
98 Patients Enrolled for Retinal Detachment
Nimesh A. Patel, MDPrincipal InvestigatorMassachusetts Eye and Ear

Media Library

Pars plana vitrectomy Clinical Trial Eligibility Overview. Trial Name: NCT05331664 — Phase 4
Retinal Detachment Research Study Groups: Group 2, Group 1
Retinal Detachment Clinical Trial 2023: Pars plana vitrectomy Highlights & Side Effects. Trial Name: NCT05331664 — Phase 4
Pars plana vitrectomy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05331664 — Phase 4
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