NCT01280929|CompletedPhase 2
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Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
NIH
interventional
54
1 country
7
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)The purpose of this trial is to evaluate safety and to compare the efficacy of intravitreous injection of ranibizumab alone (0.5 mg), versus combination of intravitreous injection of ranibizumab (0.5 mg) plus panretinal photocoagulation, versus panretinal photocoagulation alone in the regression of retinal neovascularization in eyes with high-risk proliferative diabetic retinopathy.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
January 20, 2011
Actual (reported)January 21, 2011
Actual (reported)December 2013
Actual (reported)December 2013
Actual (reported)Regression of neovascularization
To demonstrate superiority of one of the treatment arms: ranibizumab 0.5 mg monotherapy, panretinal photocoagulation monotherapy or combination therapy (ranibizumab 0.5 mg plus panretinal photocoagulation) over a 12-month treatment period in the regression of neovascularization.
12-month treatment
Changes from baseline in Best-Corrected Visual Acuity
12-month treatment
Changes from baseline in macular retinal thickness by Optical Coherent Tomography
12-month treatment
Recurrence of neovascularization
12-month treatment
Number of treatments needed
12-month treatment
Additional focal or grid laser for Diabetic Macular Edema
12 month treatment
Group 1: Panretinal photocoagulation treatment (PRP) at month-0 that can be repeated after month-3.
Group 2: Intravitreous injections of ranibizumab every 4 weeks at month-0, month-1 and month-2 that can be repeated after month-3.
Group 3: Combination treatment of ranibizumab intravitreous injections plus PRP (2 weeks +/- 1 week after injection), at month-0, month-1 and month-2 that can be repeated after month-3.
Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image
Coimbra, 3000-548, Portugal
Espaço Médico de Coimbra
Coimbra, 3030-163, Portugal
ALM Oftalmolaser
Lisbon, 1050-078, Portugal
Instituto de Retina de Lisboa
Lisbon, 1050-085, Portugal
Instituto de Oftalmologia Dr. Gama Pinto
Lisbon, 1169-019, Portugal
Instituto CUF
Porto, 4100-180, Portugal
Hospital de São João
Porto, 4200-319, Portugal
Figueira J, Silva R, Henriques J, Caldeira Rosa P, Lains I, Melo P, Goncalves Nunes S, Cunha-Vaz J. Ranibizumab for High-Risk Proliferative Diabetic Retinopathy: An Exploratory Randomized Controlled Trial. Ophthalmologica. 2016;235(1):34-41. doi: 10.1159/000442026. Epub 2015 Dec 3.
José Cunha-Vaz, MD, PhD
Association for Innovation and Biomedical Research on Light and Image
João Figueira, MD
Center for Clinical Trials - Association for Innovation and Biomedical Research on Light and Image
54 participants (actual enrollment reported by the registry).
First Submitted
January 20, 2011
First Posted
January 21, 2011
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
A Pilot Study for the Treatment of Iris Neovascularization With Macugen
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
December 2013
Actual (reported)Study Completion
December 2013
Actual (reported)Last Updated
October 8, 2015
Record last verified: 2015-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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