CompletedPhase 3

Efficacy and Safety of Ranibizumab in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

Austria, Canada, France277 participantsStarted 2010-10

Plain-language summary

This study is designed to evaluate the efficacy and safety of two different dosing regimens of 0.5 mg ranibizumab given as intravitreal injection in comparison to verteporfin PDT in patients with visual impairment due to choroidal neovascularization (CNV) secondary to pathologic myopia (PM).

Who can participate

Age range18 Years

SexALL

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: * Visual impairment due to choroidal neovascularization (CNV) secondary to PM * Best corrected visual acuity (BCVA) in the study eye \> 24 and \< 78 Early Treatment Diabetic Retinopathy Study (ETDRS) letters * High myopia (\> -6D), anterior-posterior elongation \> 26 mm; posterior changes compatible with the pathologic myopia * Either lesion types in the study eye: subfoveal, juxtafoveal, extrafoveal Exclusion Criteria: * Patients with uncontrolled systemic or ocular diseases * Blood pressure \> 150/90 mmHg * History of pan-retinal, focal/grid laser photocoagulation or intraocular treatment with any anti-VEGF or vPDT in the study eye * Intravitreal treatment with corticosteroids or intraocular surgery within last 3 months in the study eye Other protocol-defined inclusion/exclusion criteria may apply

What they're measuring

Average Change From Baseline to Month 1 Through Month 3 on Visual Acuity of the Study Eye

Timeframe: Baseline, Month 1 through Month 3

Trial details

NCT IDNCT01217944

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-08

Results submitted2013-08-14

View on ClinicalTrials.gov More Pathological Myopia trials