Ranibizumab (Lucentis) for Macular Edema Secondary to Vein Occlusions

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Peter A Campochiaro, MD
Study ID
NCT00407355
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Macular Edema
  • Retinal Vein Occlusion

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

Central and branch retinal vein occlusions are major causes of visual loss. Hemorrhage and capillary nonperfusion, when they involve the macula, can contribute to visual loss, but the major cause is macular edema. Focal and grid laser photocoagulation can sometimes provide benefit in patients with macular edema due to branch vein occlusions, but several laser treatments are often needed and recovery of vision can be very slow and incomplete 1. Laser photocoagulation does not provide benefit for macular edema due to central vein occlusions 2. Therefore, new treatments are needed.The objective of this study is to assess the bioactivity of 3 intravitreous injections 0.5 mg or 0.3 mg of ranibizumab in patients with macular edema due to central and branch retinal vein occlusions and correlate activity with peak and trough aqueous levels. The purpose of this research protocol is pilot study to determine if a randomized placebo controlled trial is warranted.

Key Dates

First listed
Dec 5, 2006
Start date
Jan 31, 2006
Status verified
Oct 2013
Primary completion
Feb 28, 2013
Completion
Feb 28, 2013

Study Design

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

Arms

  • Active Comparator: RBZ 0.3
    RBZ at the 0.3 mg dose intravitreal injection
  • Active Comparator: RBZ 0.5
    RBZ dose level .5 for ITV injection

Primary Outcome Measure

Best Corrected Visual Acuity Change From Baseline at All Visits [ Time Frame: continuous through 72 mos ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wilmer Eye InstituteBaltimoreMaryland21287-

Find similar trials in Baltimore, MD

By research site
Wilmer Eye Institute· Baltimore, MD

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