Disease-modification of advanced retinal disease secondary to diabetes mellitus

Phase 1

• Conditions: proliferative diabetic retinopathy; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2017-003193-14-AT
• Lead Sponsor: Department of Ophthalmology, MUW

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-25
• Last Update Posted: 29 November 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Active proliferative diabetic retinopathy (ETDRS severity 61 or higher)
Diagnosis of type 1 or type 2 diabetes
= 18 years of age
Written informed consent to participate in the study

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Intravitreal injection of any Anti-VEGF therapy in the study eye within 6 months prior to study inclusion
Intraocular surgery, laser therapy (argon or YAG) in the study eye within 3 months prior to study inclusion
Uncontrolled glaucoma
Media opacities in the study eye
Cardiovascular event within the past 6 months
Allergy to study drug or to fluorescein
retinal traction/detachment caused by proliferative membrane
Active intraocular inflammation (grade trace or above) in the study eye, like infectious conjunctivitis, scleritis, endophthalmitis as well as idiopathic or autoimmune-associated uveitis
Systemic anti-VEGF or pro-VEGF treatment within four months prior to randomization or anticipated use during the study.
Individual is expecting to move out of the area of the clinical center during the study period of 36 months..
pregnant or breast-feeding women

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the change in ETDRS diabetic retinopathy severity score from baseline to m12 and to m36<br>;Secondary Objective: The secondary objectives also cover parameters related to vascular integrity and its improvement under repeated aflibercept treatment;Primary end point(s): The proportion of study eyes with DRSS improvements of 1 step or more<br>The proportion of study eyes with DRSS improvement of 2 steps or more<br>The proportion of study eyes with DRSS improvement of 3 steps or more<br>The mean change (standard deviation) in DRSS;Timepoint(s) of evaluation of this end point: Month 12 and 36

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Proportion of study eyes exhibiting a specific feature (such as microaneurysms, vessel loops, capillary dropout, intraretinal microvascular abnormalities, venous beading, and potentially yet undescribed phenomena)<br>Proportion of study eyes with regression of proliferative membrane<br>Mean change in peripheral visual field<br>Mean change in best corrected visual acuity<br>Mean change in capillary vessel density<br>Mean change in capillary fractal index<br>Mean change in area of non-perfused capillaries<br>Mean change in oxigen saturation in venules and areriols<br>Characterization of cytokine levels in the aqueous humor and change following anti-VEGF treatment;Timepoint(s) of evaluation of this end point: monthly or annually, dependent on the imaging method applied