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Clinic Patients for Macular Edema (P3F2 Trial)

N/A

Waitlist Available

Led By Peter Campochiaro, MD

Research Sponsored by Johns Hopkins University

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 up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This study will examine potential factors in the aqueous humor that may contribute to the development or progression of macular edema or fibrosis (due to any underlying disease) in patients suffering from these conditions.

Eligible Conditions

Retinal Scarring
Macular Edema
Cystoid Macular Edema

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: OR PatientsExperimental Treatment2 Interventions

Patients undergoing surgery for one of the following conditions: (1) Proliferative Diabetic Retinopathy, (2) rhegmatogenous retinal detachment with PVR, (3) rhegmatogenous retinal detachment without PVR, (4) macular pucker, (5) macular hole. Surgical patients who agree to participate will have an anterior chamber (AC) tap at the beginning of surgery.

Group II: Clinic PatientsExperimental Treatment2 Interventions

Patients from the clinic will be considered for enrollment if they are receiving an intraocular injection of a steroid as part of standard care for macular edema or progressive fibrosis. Clinic patients who are receiving an intraocular injection of steroid (Ozurdex) as part of standard care who agree to participate will have an anterior chamber (AC) tap just prior to the intraocular injection of steroid and a second AC tap at a follow up visit 6 ± 2 weeks after the steroid injection.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ozurdex

2013

Completed Phase 4

~240

Surgery

2000

Completed Phase 3

~2490