Naive Patients With Uncomplicated Proliferative Diabetic Retinopathy Clinical Trial
Official title:
Phase 2 Study of Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.
| NCT number | NCT02151695 |
| Other study ID # | mEdICARE |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | May 2015 |
| Est. completion date | March 6, 2020 |
| Verified date | March 2019 |
| Source | Poitiers University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 41 |
| Est. completion date | March 6, 2020 |
| Est. primary completion date | October 31, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Chu de Poitiers | Poitiers |
| Lead Sponsor | Collaborator |
|---|---|
| Poitiers University Hospital |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of patients with regression of retinal neovascularization between baseline and 12th month. | 12 months |