REtinal Vein OccLUsion Treatment With Scatter Laser Guided by UWFA in combiNAtion With Ranibizumab Study

Part of paid clinical trials in Tampa, Florida.

Sponsor
Retina Associates of Florida, P.A.
Study ID
NCT01247220
Phase
PHASE2
Status
Completed

Conditions

  • Branch Retinal Vein Occlusion
  • Macular Edema

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Ranibizumab — DRUG
    Intravitreal Ranibizumab 0.5 mg
  • Peripheral Laser — PROCEDURE
    Angiography-directed peripheral laser

Study Details

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

Key Dates

First listed
Nov 24, 2010
Start date
Nov 30, 2010
Status verified
Oct 2014
Primary completion
May 31, 2014
Completion
May 31, 2014

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Peripheral Laser + Ranibizumab
    Angiography-directed peripheral laser + ranibizumab
  • Active Comparator: Ranibizumab
    Ranibizumab

Primary Outcome Measure

Visual Acuity [ Time Frame: 6 and 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Retina Associates of Florida, P.A.TampaFlorida33609-

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