Study of 2.0 mg Ranibizumab in Subjects With Ischemic Central Retinal Vein Occlusion (RAVE2)

Part of paid clinical trials in Houston, Texas.

Sponsor
David M. Brown, M.D.
Study ID
NCT01225146
Phase
PHASE1
Status
Terminated

Conditions

  • Eye Diseases
  • Ischemia
  • Pathologic Processes
  • Retinal Diseases
  • Retinal Vein Occlusion

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • ranibizumab — DRUG
    Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution.

Study Details

The RAVE 2 trial is a phase I, open label, 12-month trial of intravitreal ranibizumab 2.0 mg in patients with ischemic CRVO who have been either previously treated with ranibizumab or treatment naïve.

Key Dates

First listed
Oct 20, 2010
Start date
Oct 31, 2010
Status verified
May 2017
Primary completion
Aug 31, 2012
Completion
Aug 31, 2012

Study Design

Enrollment
8 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Treatment Experienced (Cohort 1
    Previously treated with 6 or more intravitreal ranibizumab with persistent edema followed in RAVE 1 (FVF3348s). Cohort 1 patients will receive 1 dose of ranibizumab 2.0 mg, followed by PRN based on pre-defined retreatment criteria
  • Active Comparator: Treatment Naive (Cohort 2)
    Treatment naïve. Cohort 2 patients will receive 6 doses of ranibizumab 2.0 mg, followed by PRN based on pre-defined re-treatment criteria.

Primary Outcome Measure

Mean Change in logMAR [ Time Frame: 12 months. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Retina Consultants of HoustonHoustonTexas77030-

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Retina Consultants of Houston· Houston, TX

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