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

Novartis

Status and phase: Completed; Phase 3

Conditions: Central Retinal Vein Occlusion

Treatments: Drug: Ranibizumab 0.5 mg; Other: Sham injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT01976312

CRFB002E2302

Details and patient eligibility

About

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

Enrollment: 252 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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252 participants in 2 patient groups

Ranibizumab 0.5 mg

Experimental group

Description:

PRN intravitreal injection

Treatment:

Drug: Ranibizumab 0.5 mg

Sham injection

Sham Comparator group

Description:

As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections

Treatment:

Other: Sham injection