Prospective, randomized, multicenter, open label phase II study to access efficacy and safety of Lucentis monotherapy (ranibizumab 0.5 mg intravitreal injections) compared with Lucentis plus panretinal photocoagulation (PRP) and PRP (monotherapy) in the treatment of patients with high risk proliferative diabetic retinopathy. -

• Conditions: Proliferative Diabetic Retinopathy.; MedDRA version: 12.0Level: LLTClassification code 10036857Term: Proliferative diabetic retinopathy

• Registration Number: EUCTR2009-014409-15-PT
• Lead Sponsor: AIBILI - Association for Innovation and Biomedical Research on Light and Image

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-09
• Last Update Posted: 18 January 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Key Inclusion Criteria:
1.High-risk proliferative diabetic retinopathy (HR-PDR) eyes.
2.BCVA at baseline > 20/320 (25 letters in the ETDRS Chart) in the study eye.
3.Clear ocular media and adequate pupillary dilatation to permit good quality fundus photography.
4.Intraocular pressure < 21 mmHg.
GENERAL CRITERIA
1.Type I, or Type II diabetic subjects as defined by the WHO criteria of either gender, and aged = 18 years .
2.Women must be using effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile.
3.Ability to provide written informed consent.
4.Ability to return for all trial visits.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Key Exclusion Criteria:
1.Eyes with prior scatter (panretinal) or focal/grid photocoagulation, within the previous 6 months.
2.Fibrovascular proliferation with retinal traction.
3.Other cause of retinal neovascularization (retinal vein occlusion, radiation retinopathy or others).
4.Atrophy/scarring/fibrosis/ hard exudates involving the center of the macula.
5.Subjects who have received YAG laser, or peripheral retinal cryoablation, or laser retinopexy (for retinal tears only), or focal/grid photocoagulation, within the previous 6 months.
6.Significant media opacities, which might interfere with visual acuity, assessment of toxicity or fundus photography.
7.Subjects should not be entered if there is likelihood that they will require cataract surgery within the following 1 year.
8.Any intraocular surgery within 6 months before trial enrolment.
9.Previous vitrectomy.
10.HbA1C level >11% or recent signs of uncontrolled diabetes.
11.Any of the following underlying systemic diseases:
• History or evidence of severe cardiac disease, e.g. NYHA Functional Class III or IV, clinical or medical history of unstable angina, acute coronary syndrome, myocardial infarction, or revascularization procedure within 6 months prior to baseline, or ventricular tachyarrhythmia requiring treatment.
• History or evidence of clinically significant peripheral vascular disease such as intermittent claudication or prior amputation.
• Clinically significant impaired renal function (serum creatinine >2.5 mg/dL or s/p renal transplant or receiving dialysis).
• Clinically significant impaired hepatic function.
• Stroke (within 12 months of trial entry).
• Any major surgical procedure within one month before trial enrolment.
12.Previous radiation to the head in the region of the study eye.
13.Any prior treatment with an investigational agent for diabetic retinopathy or anti-VEGF therapy (including intravitreal, subconjunctival or subtenons corticosteroids) during the past 90 days for any other condition.
14.Known serious allergies to fluorescein used in angiography, or to components of Lucentis® formulation.
15.Systolic BP > 170 (2 different readings) or diastolic BP > 100 (2 different readings).
16.Acute ocular or periocular infection.
17.Previous filtering surgery (e.g., trabeculectomy) or placement of a glaucoma drainage device (e.g., tube-shunt surgery).

Study & Design

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