Prospective, Randomized, Multicenter, Open Label, Phase II Study to Access Efficacy and Safety of… (NCT01280929) | Clinical Trial Compass
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 range18 Years
SexALL
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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…