Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.
Phase 2 Study of Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.
1 other identifier
interventional
41
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2015
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 28, 2014
CompletedFirst Posted
Study publicly available on registry
May 30, 2014
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 6, 2020
CompletedMarch 10, 2020
March 1, 2019
3.5 years
May 28, 2014
March 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients with regression of retinal neovascularization between baseline and 12th month.
12 months
Study Arms (2)
Panretinal photocoagulation
ACTIVE COMPARATORAflibercept intravitreal injections
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu de Poitiers
Poitiers, France
Study Officials
- PRINCIPAL INVESTIGATOR
Nicolas LEVEZIEL, MD, PhD
Poitiers University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2014
First Posted
May 30, 2014
Study Start
May 1, 2015
Primary Completion
October 31, 2018
Study Completion
March 6, 2020
Last Updated
March 10, 2020
Record last verified: 2019-03