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Corticosteroid

Dextenza for Diabetic Retinopathy

Phase 4
Waitlist Available
Led By Robert Feldman, MD
Research Sponsored by Ophthalmic Consultants of the Capital Region
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 days
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing whether a sustained-release steroid insert is better than usual steroid drops in preventing a certain complication after cataract surgery in diabetic patients.

Eligible Conditions
  • Diabetic Retinopathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dexamethasone
Secondary study objectives
Difference patients with absence of anterior chamber (AC) cells at Day 30 post op
Difference patients with absence of anterior chamber (AC) cells at Day 60 post op
Difference patients with absence of anterior chamber (AC) cells at Day 7 post op
+6 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 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
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.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: DextenzaExperimental Treatment1 Intervention
Sustained release Dexamethasone 0.4mg
Group II: Prednisolone Acetate 1%Active Control1 Intervention
Prednisolone Acetate Ophthalmic drops

Find a Location

Who is running the clinical trial?

Ophthalmic Consultants of the Capital RegionLead Sponsor
Robert Feldman, MDPrincipal InvestigatorOphthalmic Consultants of the Capital Region
4 Previous Clinical Trials
165 Total Patients Enrolled
~6 spots leftby Nov 2025
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