Widefield Angiography Guided Targeted-retinal Photocoagulation Combined With Anti VEgf Intravitreal Injections for the Treatment of Ischemic Central Retinal Vein Occlusion, Hemi Retinal Vein Occlusion, and Branch Retinal Vein Occlusion

Conditions

• Central Retinal, Hemi Retinal & Brach Retinal Vein Occlusions

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 0.5mg Ranibizumab — DRUG
  intravitreal injections
• Targeted Pan Retinal Photocoagulation — PROCEDURE
  Targeted Pan Retinal Photocoagulation based on wide field angiography

Study Details

To see if Lucentis 0.5mg combined with Targeted Pan Retinal photocoagulation will decrease the total number of intravitreal injections in a year for ischemic central retinal vein occlusion, hemi-retinal vein occlusions and branch retinal vein occlusions compared to standard of care

Key Dates

First listed

Oct 19, 2012

Start date

Oct 31, 2012

Status verified

Aug 2017

Primary completion

Oct 31, 2015

Completion

Oct 31, 2015

Study Design

Enrollment

30 participants (actual)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Targeted Pan Retinal laser combined with 0.5mg ranibizumab
  Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.
• Active Comparator: Ranibizumab 0.5mg
  Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.

Primary Outcome Measure

Total Number of Intravitreal Injections Over a 12 Month Period [ Time Frame: 12 months ]

Locations (3)

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