Study of efect of intravitreal aflibercept in subjects with prolipherative diabetic retinopathy

Phase 1

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

• Registration Number: EUCTR2013-004203-39-CZ
• Lead Sponsor: Fakultní nemocnice Královské Vinohrady

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-06
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1.Adults = 18 years with type 1 or 2 diabetes mellitus.
2.Subjects with PDR secondary to diabetes mellitus ( confirmed on fluorescein angiography FA)
3.BCVA ETDRS letter score of 20/20 to 20/320 in the study eye
4.Willing and able to comply with clinic visits and study-related procedures.
5.Provide a signed informed consent form (ICF)

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 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

A subject who meets any of the following criteria will be excluded from the study.
1.Decrease in vision determined to be primarily the result of DME in the study eye
2.Laser quadrant or panretinal photocoagulation in the study eye
3.Previous treatment with anti-antiangiogenic drugs in study eye (pegaptanib sodium, bevacizumab, ranibizumab etc.) within 90 days of Baseline visit
4.Proliferative diabetic retinopathy in the study eye, with the inactive, regressed vessels
5.Any intraocular surgery within 28 days of Baseline visit in the study eye
6.Presence of tractional or rhegmatogenous retinal detachment in the study eye
7.Any active ocular or/and periocular inflammation or infection in the study eye at Screening or Baseline visits
8.Intraocular pressure (IOP) = 30 mmHg in the study eye at Screening or Baseline visits
9.Concurrent disease in the study eye, other than PDR, that could require medical or surgical intervention during the study period, or could confound interpretation of the results (including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause)
10.Ocular media of insufficient quality to obtain fundus images and ERG (e.g., cataract, corneal opacity, severe vitreous haemorrhage)
11.Uncontrolled blood pressure defined as systolic value of >160 mmHg or diastolic value >100 mmHg eye at Screening or Baseline visits
12.Stroke or and/or myocardial infarction less than 3 months prior to Baseline visit
13.Pregnant or breast-feeding women.
14.Hypersensitivity to aflibercept or to fluorescein

Study & Design

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