Evaluation of the "Treat-and-extend" Scheme in Patients With Retinal Vein Occlusion (RVO) With and Without LASER Treatment of Ischaemic Retinal Areas

Sponsor
PD. Dr. med. Armin Wolf
Study ID
NCT02522897
Phase
PHASE4
Status
Unknown

Conditions

  • Central Retinal Vein Occlusion With Macular Edema

Eligibility Criteria

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

Interventions

Study Details

The purpose of this study is to determine if additional panretinal photocoagulation of ischemic areas following retinal vein occlusion (RVO) may reduce the rate of recurrence and allow longer treatment intervals in anti-Vascular Endothelial Growth Factor (VEGF) treatment following the "trea-and-extend" scheme.

Key Dates

First listed
Aug 13, 2015
Start date
Aug 31, 2015
Status verified
Aug 2015
Primary completion
Jan 31, 2018
Completion
Jan 31, 2018

Study Design

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

Arms

  • Active Comparator: Ranibizumab
    Patients receive intravitreal injections of 0,5 mg Ranibizumab (Lucentis®) / injection following the "treat-and-extend" scheme for 12 months.
  • Experimental: Ranibizumab + Laser
    Apart from receiving intravitreal injections of 0,5 mg Ranibizumab (Lucentis®) / injection following the "treat-and-extend" scheme for 12 months, patients receive a panretinal photocoagulation on visit 3 and / or 4.

Primary Outcome Measure

Differences in the length of the treatment-free interval in patients with or without panretinal photocoagulation [ Time Frame: within 12 months after first injection of Ranibizumab ]

Central Contacts