Clinical Trial: Prospective, Randomized, Multicentre, Open-label, Phase II / III Study to Assess Efficacy and Safety of Ranibizumab 0.5 mg Intravitreal Injections Plus Panretinal Photocoagulation (PRP) Versus PRP in Monotherapy in the Treatment of Subjects With High Risk Proliferative Diabetic Retinopathy.

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Prospective, Randomized, Multicentre, Open-label, Phase II / III Study to Assess Efficacy and Safety of Ranibizumab 0.5 mg Intravitreal Injections Plus Panretinal Photocoagulation (PRP) Versus PRP in

Brief Summary:

This study is a prospective, randomized, multicentre, open label study that intents to compare the efficacy and safety of ranibizumab 0.5 mg Intravitreal (ITV) injections plus Panretinal Photocoagulation versus Panretinal Photocoagulation alone in the regression of the neovascularization area in patients with High Risk Proliferative Diabetic Retinopathy over a 12-month treatment period.

One of the major complications of the diabetes mellitus is Diabetic Retinopathy (DR), one of the leading causes of visual impairment in working age in industrialized countries. Longer diabetes duration and poor glycaemic and blood pressure control are strongly associated with Diabetic Retinopathy. The overall prevalence of any form of Diabetic Retinopathy is 34.4% and 6.96% corresponds to Proliferative Diabetic Retinopathy (PDR). Therefore, approximately 93 million people have Diabetic Retinopathy and 17 million of them have Proliferative Diabetic Retinopathy.

It has been shown that treatment with repeated injections of ranibizumab can improve visual acuity in patients with PDR. Further, , the standard PRP treatment of PDR remains unsatisfactory. The knowledge of the mechanisms of this retinal complication is incomplete and, therefore, efforts should be done to understand and characterize patients' eyes response to combined treatments.

Therefore, the purpose of this study is to compare the standard treatment for PDR (i.e. Panretinal Photocoagulation) with Panretinal Photocoagulation treatment combined with ITV injections of ranibizumab since it is expected that anti-vascular endothelial growth factor (VEGF) treatment with ITV injections will increase the rate of success of Panretinal Photocoagulation in regression of neovascularization with improved final visual acuity.


Detailed Summary:
Sponsor: Association for Innovation and Biomedical Research on Light and Image

Current Primary Outcome: Regression of neovascularization [ Time Frame: 12-month treatment ]

Defined as any decrease in the area of neovascularization


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes in Best Corrected Visual Acuity (BCVA) [ Time Frame: 12-Month treatment ]
  • Time to complete neovascularization regression [ Time Frame: 12-Month treatment ]
  • Recurrence of neovascularization [ Time Frame: 12-Month treatment ]
  • Macular retinal thickness [ Time Frame: 12-Month treatment ]
  • Need of treatment for Diabetic Macular Edema [ Time Frame: 12-Month treatment ]
  • Need of vitrectomy due to the occurrence of vitreous hemorrhage, tractional retinal detachment or other complications of Diabetic Retinopathy. [ Time Frame: 12-Month treatment ]
  • Adverse events related to the treatments [ Time Frame: 12-Month treatment ]


Original Secondary Outcome: Same as current

Information By: Association for Innovation and Biomedical Research on Light and Image

Dates:
Date Received: September 10, 2013
Date Started: April 2014
Date Completion: May 2017
Last Updated: May 16, 2017
Last Verified: May 2017