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Anti-VEGF Therapy

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 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.

Find a Location

Who is running the clinical trial?

Palmetto Retina Center, LLCLead Sponsor
2 Previous Clinical Trials
195 Total Patients Enrolled
PfizerIndustry Sponsor
4,644 Previous Clinical Trials
17,743,067 Total Patients Enrolled
1 Trials studying Branch Retinal Vein Occlusion
180 Patients Enrolled for Branch Retinal Vein Occlusion
Eyetech PharmaceuticalsIndustry Sponsor
14 Previous Clinical Trials
3,067 Total Patients Enrolled
~1 spots leftby Oct 2025