Recruitment

Recruitment Status
Completed

Inclusion Criterias

Systolic blood pressure <160 mmHg and diastolic blood pressure <105 mmHg at study entry
HbA1c <11.6% at study entry
Patients with diabetes mellitus type 1 or type 2 complicated by PDR
...
Systolic blood pressure <160 mmHg and diastolic blood pressure <105 mmHg at study entry
HbA1c <11.6% at study entry
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
Male or female over 18 years

Exclusion Criterias

Hypersensitivity to aflibercept or to any of the excipients
Patients with significant medical problems that may interfere with the evaluation of the safety or efficacy of the treatment studied
Florid diabetic retinopathy
...
Hypersensitivity to aflibercept or to any of the excipients
Patients with significant medical problems that may interfere with the evaluation of the safety or efficacy of the treatment studied
Florid diabetic retinopathy
History of retinal laser (macular or panretinal photocoagulation), of intravitreal injections, of vitrectomy in the eye studied
Other eye disease in the eye studied
Unbalanced glaucoma in the eye studied
PDR associated with fibrovascular proliferation in the eye studied
Eye infection or periocular active or suspected
PDR associated with tractional retinal detachment 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 Criterias

Systolic blood pressure <160 mmHg and diastolic blood pressure <105 mmHg at study entry
HbA1c <11.6% at study entry
Patients with diabetes mellitus type 1 or type 2 complicated by PDR
...
Systolic blood pressure <160 mmHg and diastolic blood pressure <105 mmHg at study entry
HbA1c <11.6% at study entry
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
Male or female over 18 years

Exclusion Criterias

Hypersensitivity to aflibercept or to any of the excipients
Patients with significant medical problems that may interfere with the evaluation of the safety or efficacy of the treatment studied
Florid diabetic retinopathy
...
Hypersensitivity to aflibercept or to any of the excipients
Patients with significant medical problems that may interfere with the evaluation of the safety or efficacy of the treatment studied
Florid diabetic retinopathy
History of retinal laser (macular or panretinal photocoagulation), of intravitreal injections, of vitrectomy in the eye studied
Other eye disease in the eye studied
Unbalanced glaucoma in the eye studied
PDR associated with fibrovascular proliferation in the eye studied
Eye infection or periocular active or suspected
PDR associated with tractional retinal detachment in the eye studied

Locations

Poitiers
Poitiers

Tracking Information

NCT #
NCT02151695
Collaborators
Not Provided
Investigators
  • Principal Investigator: Nicolas LEVEZIEL, MD, PhD Poitiers University Hospital
  • Nicolas LEVEZIEL, MD, PhD Poitiers University Hospital