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OpenTrials
Completed

NCT Number: NCT02151695

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.

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Key information

Conditions

Naive Patients With Uncomplicated Proliferative Diabetic Retinopathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Chu de Poitiers

Poitiers, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Panretinal Photocoagulation

Procedure

Aflibercept intravitreal injections

Drug

Primary outcomes

  1. Percentage of patients with regression of retinal neovascularization between baseline and 12th month.

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2020
First posted
May 30, 2014
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.