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Ranibizumab Intravitreal Injections Versus Sham Control in Patients With Branch Retinal Vein Occlusion (BRVO) (Blossom)

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Novartis

Status and phase

Completed
Phase 3

Conditions

Macular Edema Secondary to Branch Retinal Vein Occlusion

Treatments

Other: Sham injection
Drug: Ranibizumab 0.5 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT01976338
CRFB002E2303

Details and patient eligibility

About

Provided efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to BRVO

Enrollment

283 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

• Patients with visual impairment secondary to branch retinal vein occlusion (BRVO) with a BCVA between 19 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 without 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 few months

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

283 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 6 ranibizumab 0.5 mg PRN intravitreal injection
Treatment:
Other: Sham injection

Trial contacts and locations

33

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Data sourced from clinicaltrials.gov

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