NCT01003106

Ranibizumab DosE Comparison and the Role of LAser in REtinal Vein Occlusions

RanibizumabDosE Comparison (0.5mg and 2.0mg) and the Role of LAser in the ManagemenT of REtinal Vein Occlusion - A Pharmacodynamic Approach(RELATE)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Peter A Campochiaro, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary Objective of this study is to evaluate the safety and tolerability of intraocular injections of 0.5mg or 2.0mg of ranibizumab in patients with macular edema due to retinal vein occlusion.

Detailed description

The secondary objectives are to assess the efficacy of 0.5mg versus 2.0mg of monthly ranibizumab injections in patients with macular edema due to retinal vein occlusion between baseline and month 6. At week 24, patients will be re-randomized to receive pro re nata (prn) ranibizumab+laser photocoagulation versus ranibizumab alone and the efficacy of both treatment options will be compared. Treatment efficacy will be assessed by comparing changes in best corrected visual acuity (BCVA) and central subfiled thickness (CST) between the treatment groups.

Conditions

• Retinal Vein Occlusion

Interventions

Type	Name	Description
DRUG	Ranibizumab 0.5mg (monthly)	Branch retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone
DRUG	Ranibizumab 2.0mg (monthly)
DRUG	Pro re nata (prn) ranibizumab
PROCEDURE	Pro re nata (prn) Laser photocoagulation

Timeline

• Start date: 2009-11-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2009-10-28
• Last updated: 2016-03-15
• Results posted: 2016-03-15

Locations

1 site across 1 country: United States