Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.
NCT ID: NCT02151695
Last Updated: 2020-03-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
41 participants
INTERVENTIONAL
2015-05-31
2020-03-06
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
Study Groups
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Panretinal photocoagulation
panretinal photocoagulation
Aflibercept intravitreal injections
Aflibercept intravitreal injections
Interventions
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panretinal photocoagulation
Aflibercept intravitreal injections
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Poitiers University Hospital
OTHER
Responsible Party
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Principal Investigators
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Nicolas LEVEZIEL, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Poitiers University Hospital
Locations
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Chu de Poitiers
Poitiers, , France
Countries
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Other Identifiers
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mEdICARE
Identifier Type: -
Identifier Source: org_study_id
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