Overview

Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Central Retinal Vein Occlusion (CRVO)

Status:
Completed
Trial end date:
2016-03-14
Target enrollment:
0
Participant gender:
All
Summary
Provide efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to CRVO
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
Ranibizumab
Criteria
Inclusion Criteria for study and fellow eye:

• Patients with visual impairment secondary to central retinal vein occlusion (CRVO) with a
BCVA between 24 and 73 letters in one eye and at least 35 letters in the other eye.

Exclusion Criteria:

- Pregnant or nursing women or women of child bearing potential unless using an
effective contraception

- Stroke or myocard infarction within 3 months prior to study

- History of malignancy within the past 5 years

- Uncontrolled hypertension

- Active infection or inflammation in any eye

- use of corticosteroids for at least 30 days in the last 6 months

- treatment with anti-angiogenic drugs in any eye within last 3 months

- Panretinal or focal/drid laser photocoagulation within the last 3 and 4 months
respectively