Evaluation of Macugen Treatment of Macular Edema Due to Branch Retinal Vein Occlusion
Condition: Branch Retinal Vein Occlusion
MeSH terms: Macular Edema; Retinal Vein Occlusion
Intervention: pegaptanib sodium (Macugen)
Intervention description: Subjects were randomized 3:1 to intravitreous injections of pegaptanib 0.3mg or 1mg at baseline and at weeks 6 and 12 with subsequent injections at 6-week intervals at investigator discretion until week 48.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: branch retinal vein occlusion; macular edema; pegaptanib sodium; vascular endothelial growth factor

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Macular edema secondary to BRVO involving the foveal center in male or female patients
             at least 18 years of age

          -  Duration of BRVO macular edema less than 6 months prior to baseline visit

          -  Best corrected ETDRS visual acuity 20/40-20/320 (Snellen equivalent) using the 4
             meters testing method.

          -  Central foveal thickness greater than or equal to 250 microns using the OCT-3

          -  Less than 25% of foveal capillary ring disruption

          -  Less than 2 disc areas of capillary non-perfusion within 1000 microns of the foveal
             center

          -  Absence of hemorrhage or lipid in the foveal center

          -  Investigator comfortable deferring macular laser for 18 weeks from baseline and
             intravitreous steroid for 36 weeks from baseline

        Exclusion Criteria:

          -  Ocular conditions other than BRVO related macular edema such as significant cataract,
             diabetic retinopathy, AMD, glaucoma, uveitis, epiretinal membrane, vitreomacular
             traction or tumor.

          -  Intraocular surgery within past 3 months

          -  Significant enlargement of foveal avascular zone(>25% disruption of capillary ring) or
             greater than 2 disc areas of nonperfusion within 1000 microns of foveal center.

          -  Likelihood of evidence driven indication for peripheral photocoagulation in the next 6
             months.

          -  Patients who have shown evidence of spontaneous improvement within the preceding 3
             months, as determined by an improvement of >15 letters of vision or thinning of the
             Center Point on OCT of >20% from baseline determination

          -  Prior grid laser within 4 months of baseline or more than one prior grid laser
             treatment.

          -  No prior intravitreous or periocular steroid injections in the study eye.