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Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.

Primary Purpose

Naive Patients With Uncomplicated Proliferative Diabetic Retinopathy

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
panretinal photocoagulation
Aflibercept intravitreal injections
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Naive Patients With Uncomplicated Proliferative Diabetic Retinopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu de Poitiers

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Panretinal photocoagulation

Aflibercept intravitreal injections

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 28, 2014
Last Updated
March 9, 2020
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02151695
Brief Title
Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.
Official Title
Phase 2 Study of Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
March 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Naive Patients With Uncomplicated Proliferative Diabetic Retinopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Panretinal photocoagulation
Arm Type
Active Comparator
Arm Title
Aflibercept intravitreal injections
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
panretinal photocoagulation
Intervention Type
Drug
Intervention Name(s)
Aflibercept intravitreal injections
Primary Outcome Measure Information:
Title
Percentage of patients with regression of retinal neovascularization between baseline and 12th month.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas LEVEZIEL, MD, PhD
Organizational Affiliation
Poitiers University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu de Poitiers
City
Poitiers
Country
France

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.

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