Pegaptanib Sodium 0.3mg (Macugen) for Branch Retinal Vein Occlusion

Phase 4

Waitlist Available

Led By John A Wells, III, MD

Research Sponsored by Palmetto Retina Center, LLC

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 54 weeks

Awards & highlights

Pivotal Trial

All Individual Drugs Already Approved

No Placebo-Only Group

Approved for 5 Other Conditions

Drug Has Already Been Approved

Summary

The purpose of this study is to evaluate the effect of intravitreal injections of Macugen every 6 weeks for the treatment of macular edema secondary to branch retinal vein occlusion (BRVO). We hypothesize that macular edema secondary to BRVO is mediated by VEGF 165 and that chronic suppression of VEGF 165 will successfully treat BRVO related macular edema.

Eligible Conditions

Branch Retinal Vein Occlusion

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 54 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~54 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 54 weeks for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Safety Parameters

Awards & Highlights

Pivotal Trial

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

All Individual Drugs Already Approved

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

No Placebo-Only Group

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

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.

Trial Design

2Treatment groups

Active Control

Group I: Pegaptanib Sodium 0.3mg (Macugen)Active Control1 Intervention

Intravitreous injections of Macugen 0.3mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.

Group II: Pegaptanib Sodium 1 mg (Macugen)Active Control1 Intervention

Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.

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