CompletedPhase 3

Efficacy and Safety of Ranibizumab 0.5 vs Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

China457 participantsStarted 2013-09-11

Plain-language summary

This study was 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 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 CNV secondary to PM. * Best corrected visual acuity in the study eye \> 24 and \< 78 ETDRS letters. * High myopia (\> -6D), * anterio-posterior elongation \> 26 mm; posterior changes compatible with the pathologic myopia. * Either CNV locations in the study eye: subfoveal, juxtafoveal, extrafoveal. Exclusion Criteria: * Some preexisting eye disorders or systemic diseases;-Blood pressure \> 150/90 mmHg * Prior focal/grid laser to the macular area -History of treatment with any anti-VEGF or verteporfin PDT in the study eye * Intravitreal treatment with corticosteroids or intraocular surgery within last 3 months in the study eye

What they're measuring

Change From Baseline BCVA to the Average Level of BCVA Over All Monthly Assessments From Month 1 to Month 3

Timeframe: From Baseline to Month 3

Trial details

NCT IDNCT01922102

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2016-09-14

Results submitted2017-09-11

View on ClinicalTrials.gov More Visual Impairment Due to Choroidal Neovascularization (CNV) Secondary to Pathologic Myopia (PM) trials