Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- HbA1c <11.6% at study entry
- Systolic blood pressure <160 mmHg and diastolic blood pressure <105 mmHg at study entry
- 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
- Male or female over 18 years
- Patients with diabetes mellitus type 1 or type 2 complicated by PDR
- Backgrounds clear eye, pupil dilation and patient cooperation sufficient to allow examination or fundus photographs of good quality
Exclusion Criteria
- PDR associated with tractional retinal detachment in the eye studied
- Patients with significant medical problems that may interfere with the evaluation of the safety or efficacy of the treatment studied
- Hypersensitivity to aflibercept or to any of the excipients
- ...
- PDR associated with tractional retinal detachment in the eye studied
- Patients with significant medical problems that may interfere with the evaluation of the safety or efficacy of the treatment studied
- Hypersensitivity to aflibercept or to any of the excipients
- PDR associated with fibrovascular proliferation in the eye studied
- Florid diabetic retinopathy
- Unbalanced glaucoma in the eye studied
- Eye infection or periocular active or suspected
- History of retinal laser (macular or panretinal photocoagulation), of intravitreal injections, of vitrectomy in the eye studied
- Other eye disease in the eye studied
Summary
- Conditions
- Naive Patients With Uncomplicated Proliferative Diabetic Retinopathy
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Inclusion Criteria
- HbA1c <11.6% at study entry
- Systolic blood pressure <160 mmHg and diastolic blood pressure <105 mmHg at study entry
- 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
- Male or female over 18 years
- Patients with diabetes mellitus type 1 or type 2 complicated by PDR
- Backgrounds clear eye, pupil dilation and patient cooperation sufficient to allow examination or fundus photographs of good quality
Exclusion Criteria
- PDR associated with tractional retinal detachment in the eye studied
- Patients with significant medical problems that may interfere with the evaluation of the safety or efficacy of the treatment studied
- Hypersensitivity to aflibercept or to any of the excipients
- ...
- PDR associated with tractional retinal detachment in the eye studied
- Patients with significant medical problems that may interfere with the evaluation of the safety or efficacy of the treatment studied
- Hypersensitivity to aflibercept or to any of the excipients
- PDR associated with fibrovascular proliferation in the eye studied
- Florid diabetic retinopathy
- Unbalanced glaucoma in the eye studied
- Eye infection or periocular active or suspected
- History of retinal laser (macular or panretinal photocoagulation), of intravitreal injections, of vitrectomy in the eye studied
- Other eye disease in the eye studied
Tracking Information
- NCT #
- NCT02151695
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Nicolas LEVEZIEL, MD, PhD Poitiers University Hospital
- Nicolas LEVEZIEL, MD, PhD Poitiers University Hospital
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