Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.

Phase 2 Study of Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02151695

Enrollment

Registered

2014-05-30

Start date

2015-05-31

Completion date

2020-03-06

Last updated

2020-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Naive Patients With Uncomplicated Proliferative Diabetic Retinopathy

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.

Interventions

PROCEDUREpanretinal photocoagulation

DRUGAflibercept intravitreal injections

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percentage of patients with regression of retinal neovascularization between baseline and 12th month.	12 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026