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

NCT01217944 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 277

Last updated 2014-02-10

Study results available
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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).

Conditions

  • Pathological Myopia

Interventions

DRUG

Ranibizumab

0.5 mg ranibizumab intravitreal injection

DRUG

Verteporfin PDT

Verteporfin (6 mg/m2) intravenous infusion

DRUG

Sham Ranibizumab

Empty vial to mimic the intravitreal injection

DRUG

Sham verteporfin PDT

Sham vPDT intravenous infusion of dextrose 5% solution followed by light application (PDT).

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • Austria
  • Canada
  • France
  • Germany
  • Hong Kong
  • Hungary
  • India
  • Italy
  • Japan
  • Latvia
  • Lithuania
  • Poland
  • Portugal
  • Singapore
  • Slovakia
  • South Korea
  • Spain
  • Switzerland
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01217944 on ClinicalTrials.gov