Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Peter A Campochiaro, MD
Study ID
NCT01003106
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Retinal Vein Occlusion

Eligibility Criteria

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

Interventions

Study Details

The primary Objective of this study is to evaluate the safety and tolerability of intraocular injections of 0.5mg or 2.0mg of ranibizumab in patients with macular edema due to retinal vein occlusion.

Key Dates

First listed
Oct 28, 2009
Start date
Nov 30, 2009
Status verified
Feb 2016
Primary completion
Apr 30, 2015
Completion
Apr 30, 2015

Study Design

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

Arms

  • Experimental: BRVO- Ranibizumab 0.5mg alone
    Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation.
  • Experimental: BRVO- Pro re nata (prn) ranibizumab with laser
    Branch retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, and additional laser photocoagulation if required.
  • Experimental: BRVO- Ranibizumab 2.0mg alone
    Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.
  • Experimental: BRVO- Pro re nata (prn) ranibizumab
    Branch retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, without additional laser photocoagulation.
  • Experimental: CRVO- Ranibizumab 0.5mg alone
    Central retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation
  • Experimental: CRVO- Pro re nata (prn) ranibizumab with laser
    Central retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, and additional laser photocoagulation if required.
  • Experimental: CRVO- Ranibizumab 2.0mg alone
    Central retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.
  • Experimental: CRVO- Pro re nata (prn) ranibizumab
    Central retinal vein occlusion patients randomized to this group will receive 0.5mg/2.0mg of ranibizumab as per protocol, without additional laser photocoagulation.

Primary Outcome Measure

Incidence and Severity of Ocular and Non-ocular Adverse Events. [ Time Frame: 36 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Wilmer Eye Institute at Johns Hopkins UniversityBaltimoreMaryland21287-

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By research site
Wilmer Eye Institute at Johns Hopkins University· Baltimore, MD

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