Efficacy and Safety of Lucentis for Clinically Significant Macular Edema Secondary to Central Retinal Vein Occlusion

Sponsor
University of Pecs
Study ID
NCT01123564
Phase
PHASE2
Status
Unknown

Conditions

  • Macular Edema
  • Retinal Vein Occlusion

Eligibility Criteria

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

Interventions

  • ranibizumab — DRUG
    applied monthly in the first 3 months period, and after this only if visual acuity (VA) decreases with more than 5 letters at any monthly visits
  • Argon laser treatment — RADIATION
    Conventional grid pattern argon laser treatment and panretinal argon laser photocoagulation in an as needed basis.

Study Details

This study aims to assess if Lucentis injection applied into the eye is superior to conventional treatment concerning the prevention of visual loss in patients having clinically significant macular edema secondary to retinal vein occlusion

Key Dates

First listed
May 14, 2010
Start date
Aug 31, 2009
Status verified
May 2010
Primary completion
Sep 30, 2011
Completion
Sep 30, 2011

Study Design

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

Arms

  • Experimental: Lucentis (ranibizumab)
  • Active Comparator: Laser

Primary Outcome Measure

Efficacy compared to conventional treatment assessed by BCVA(best corrected visual acuity) [ Time Frame: 12 months ]

Central Contacts

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