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A Randomized Study Comparing Ranibizumab to Sham in Patients With Macular Edema Secondary to CRVO

NCT00567697 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2012-01-19

No results posted yet for this study

Summary

A prospective multicenter study comparing patients with CRVO amd secondary macular edema treated with ranibizumab versus sham. Safety and efficacy will be evaluated. Patients will be randomized in a 1:1 ratio to one of the two arms. 32 patients, 6 months follow up. There will be monthly visits with injection the first three months and subsequently new injection if present edema.

Conditions

  • Central Retinal Vein Occlusion
  • Macular Edema

Interventions

DRUG

ranibizumab

0.5 ml 10mg/ml (0.5 mg) ranibizumab for intravitreal injection. Monthly injection for 3 months, followed by reinjection if edema for a total of 6 months.

DRUG

ranibizumab

Sham injection with an empty, sterile 3-ml stopped glass vial. # monthly sham-injections, followed by reinjection for 3 months if present edema.

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Aleris Helse

    lead OTHER

Principal Investigators

  • Bettina Kinge, MD DMSc · Aleris Helse, Oslo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00567697 on ClinicalTrials.gov