REtinal Vein OccLUsion Treatment With Scatter Laser Guided by UWFA in combiNAtion With Ranibizumab Study
Condition: Macular Edema; Branch Retinal Vein Occlusion
MeSH terms: Macular Edema; Retinal Vein Occlusion
Intervention: Ranibizumab; Peripheral Laser
Intervention description: Intravitreal Ranibizumab 0.5 mg; Angiography-directed peripheral laser
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Macular Edema; Branch retinal vein occlusion; Ranibizumab

Summary:

      Branch retinal vein occlusion is a leading cause of vision loss. Treatment with ranibizumab
      (vascular endothelial growth factor (VEGF) inhibitor) on a monthly basis has been associated
      with improved vision results. There is a subgroup of patients with peripheral nonperfusion on
      ultrawidefield angiography that appears to be more dependent on anti-VEGF treatment.

      In this trial the investigators compare the gold standard of monthly ranibizumab injections
      with ranibizumab + peripheral scatter laser to the areas of nonperfusion on angiography. Each
      group will have monthly injections for the first six months, then as needed by either visual
      acuity decrease or increased retinal thickness for the subsequent six months.

      The primary outcome is visual acuity. Secondary outcomes are reduction in optical coherence
      tomography, and number of ranibizumab injections
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will be eligible if the following criteria are met:

          -  Ability to provide written informed consent and comply with study assessments for the
             full duration of the study

          -  Age > 18 years

               -  Disease related considerations:

               -  Study eye with macular edema secondary to branch retinal vein occlusion
                  characterized by:

          -  Fovea-involved macular edema of less than 12 months peripheral nonperfusion defined as
             at least 5 disc areas of contiguous nonperfusion on ultra-widefield fluorescein
             angiography absence of macular traction on clinical exam, UWFA, and OCT.

          -  Study eye with best corrected visual acuity between 20/40 (≤ 73 letters on ETDRS
             chart) and 20/320 (≥ 19 letters on ETDRS chart)

          -  Other considerations

          -  Patient able to complete all study visits

        Exclusion Criteria:

          -  Subjects who meet any of the following criteria will be excluded from this study:

               -  Pregnancy (positive pregnancy test) or lactation. Premenopausal women not using
                  adequate contraception. The following are considered effective means of
                  contraception: surgical sterilization or use of oral contraceptives, barrier
                  contraception with either a condom or diaphragm in conjunction with spermicidal
                  gel, an IUD, or contraceptive hormone implant or patch.

               -  Prior enrollment in the study

               -  Any other condition that the investigator believes would pose a significant
                  hazard to the subject if the investigational therapy were initiated

               -  Participation in another simultaneous medical investigation or trial

               -  Therapy with intravitreal triamcinolone, pegaptanib, ranibizumab, or bevacizumab
                  within the previous 3 months

               -  Previous macular or panretinal scatter laser photocoagulation

               -  Previous pars plana vitrectomy

               -  Visually-significant significant cataracts as primary reason for vision loss

               -  Myocardial infarction or cerebrovascular accident within 6 months