Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.

March 9, 2020 updated by: Poitiers University Hospital

Phase 2 Study of Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.

Proliferative diabetic retinopathy is a serious complication of diabetes mellitus, partly consecutive to upregulation of vascular endothelial growth factor (VEGF) as a consequence of retinal ischemia leads. Aflibercept has been approved by FDA and European medicine agency for treatment of exudative age-related macular degeneration, another retinal disease characterized by choroidal new vessels.

The aim of this pilot study is to evaluate the efficacy and the safety of Aflibercept intravitreal injections compared to panretinal photocoagulation for proliferative diabetic retinopathy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Poitiers, France
        • CHU de Poitiers

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with diabetes mellitus type 1 or type 2 complicated by PDR
  • Male or female over 18 years
  • HbA1c <11.6% at study entry
  • Systolic blood pressure <160 mmHg and diastolic blood pressure <105 mmHg at study entry
  • Backgrounds clear eye, pupil dilation and patient cooperation sufficient to allow examination or fundus photographs of good quality

Exclusion Criteria:

  • Hypersensitivity to aflibercept or to any of the excipients
  • History of retinal laser (macular or panretinal photocoagulation), of intravitreal injections, of vitrectomy in the eye studied
  • PDR associated with tractional retinal detachment in the eye studied
  • PDR associated with fibrovascular proliferation in the eye studied
  • Florid diabetic retinopathy
  • Eye infection or periocular active or suspected
  • Unbalanced glaucoma in the eye studied
  • Other eye disease in the eye studied
  • Patients with significant medical problems that may interfere with the evaluation of the safety or efficacy of the treatment studied

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Panretinal photocoagulation
Procedure: panretinal photocoagulation
Experimental: Aflibercept intravitreal injections
Drug: Aflibercept intravitreal injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients with regression of retinal neovascularization between baseline and 12th month.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Poitiers University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2015

Primary Completion (Actual)

October 31, 2018

Study Completion (Actual)

March 6, 2020

Study Registration Dates

First Submitted

May 28, 2014

First Submitted That Met QC Criteria

May 29, 2014

First Posted (Estimate)

May 30, 2014

Study Record Updates

Last Update Posted (Actual)

March 10, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • mEdICARE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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