CompletedPhase 2

Prospective, Randomized, Multicenter, Open Label, Phase II Study to Access Efficacy and Safety of Lucentis® Monotherapy Compared With Lucentis® Plus Panretinal Photocoagulation (PRP) and PRP in the Treatment of Patients With High Risk Proliferative Diabetic Retinopathy

Portugal54 participantsStarted 2010-09

Plain-language summary

The purpose of this trial is to evaluate safety and to compare the efficacy of intravitreous injection of ranibizumab alone (0.5 mg), versus combination of intravitreous injection of ranibizumab (0.5 mg) plus panretinal photocoagulation, versus panretinal photocoagulation alone in the regression of retinal neovascularization in eyes with high-risk proliferative diabetic retinopathy.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * High-risk proliferative diabetic retinopathy (HR-PDR) eyes. * Best Corrected-Visual Acuity at baseline \> 20/320 in the study eye. * Clear ocular media and adequate pupillary dilatation to permit good quality fundus photography. * Intraocular pressure \< 21 mmHg. * Type I, or Type II diabetic subjects as defined by the World Health Organization criteria of either gender, and aged ≥ 18 years. * Women must be using effective contraception, be post-menopausal for at least 12 months prior to trial entry, or surgically sterile. * Ability to provide written informed consent. * Ability to return for all trial visits. Exclusion Criteria: * Eyes with prior scatter (panretinal) or focal/grid photocoagulation, within the previous 6 months. * Fibrovascular proliferation with retinal traction. * Other cause of retinal neovascularization (retinal vein occlusion, radiation retinopathy or others). * Atrophy/scarring/fibrosis/ hard exudates involving the center of the macula. * Subjects who have received yttrium-aluminum-garnet laser, or peripheral retinal cryoablation, or laser retinopexy (for retinal tears only), or focal/grid photocoagulation, within the previous 6 months. * Significant media opacities, which might interfere with visual acuity, assessment of toxicity or fundus photography. * Subjects should not be entered if there is likelihood that they will require cataract surgery within the following 1 year. * Any intraocular surgery within 6 months before tria…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Regression of neovascularization

Timeframe: 12-month treatment

Trial details

NCT IDNCT01280929

SponsorJosé Cunha-Vaz

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-12

View on ClinicalTrials.gov More High Risk Proliferative Diabetic Retinopathy trials