CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 126 enrolled
Drug / intervention
Ranibizumab +1 moredrug
Likely dose
Ranibizumab 05mlfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00407381
NCT00407381Phase 2Completed
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Ranibizumab for Edema of the Macula in Diabetes: a Phase 2 Study ( The Read-2 Study)

Johns Hopkins University·interventional·Posted Dec 5, 2006·Updated Mar 31, 2017

In Brief

A Phase 2 clinical trial evaluating Ranibizumab and Laser photocoagulation for Diabetic Macular Edema. Completed, enrolled 126 participants across 20 sites.

Detailed Summary

This study is being done to see if the investigational drug Ranibizumab (RBZ) given by injection into the eye, is safe and effective to use in people with diabetic macular edema (DME). The investigators want to compare RBZ to laser treatment which is the current standard way to treat DME. RBZ blocks a growth factor that is thought to be involved in the formation of abnormal blood vessels that cause loss of vision in patients with DME.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Macular Edema
CountriesUnited States
CollaboratorsJuvenile Diabetes Research Foundation, Genentech, Inc.

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 5, 2006
Enrollment StartDec 1, 2006
Primary CompletionAug 1, 2010
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 19.6 years ago

Interventions

Ranibizumabdrug

Ranibizumab for intravitreal injection. .05ml dosing at 30 day intervals and pro re nata (PRN) with dosing criteria.

Laser photocoagulationprocedure

Laser photocoagulation in either focal or grid pattern as determined by investigator.