Skip to main content
OpenTrials
Completed

NCT Number: NCT01217944

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pathological Myopia Choroid Diseases Choroidal Neovascularization Eye Diseases Metaplasia Myopia Myopia, Degenerative Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Refractive Errors Uveal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Vienna, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ranibizumab

Drug

0.5 mg ranibizumab intravitreal injection

Verteporfin PDT

Drug

Verteporfin (6 mg/m2) intravenous infusion

Other names: vPDT

Sham ranibizumab

Drug

Empty vial to mimic the intravitreal injection

Sham verteporfin PDT

Drug

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

Primary outcomes

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

    Time frame: Baseline, Month 1 through Month 3

    The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and compared to the average from month 1 to month 3.

Secondary outcomes

  1. Average Change From Baseline to Month 6 in Visual Acuity of the Study Eye

    Time frame: Baseline and Month 6

    The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and month 6. The overall BCVA score was calculated using the BCVA worksheet.

  2. Average Change From Baseline to Month 1 Through Month 12 in Visual Acuity of the Study Eye

    Time frame: Baseline and Month 1 through Month 12

    The Best Corrected Visual Acuity (BCVA) was tested using the Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity (VA) testing protocol. VA measurements were taken in a sitting position at an initial test distance of 4 meters using ETDRS charts at baseline and Month 1 through 12

  3. Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 3

    Time frame: Month 3

    BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 of visual acuity at month 3.

  4. Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letters Gain or Reach 84 Letters at Month 6 and Month 12

    Time frame: Months 6 and 12

    BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the percentage of participants who gained more than 10 or more than 15 letters of visual acuity at month 6 and month 12.

  5. Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 3

    Time frame: Month 3

    BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 3.

  6. Percentage of Patients With Best Corrected Visual Acuity (BCVA) ≥10 and ≥15 Letter Loss at Month 6 and 12

    Time frame: Months 6 and 12

    BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. A decreased score indicates worsening in acuity. This outcome assessed the percentage of participants who lost more than 10 or more than 15 of visual acuity at month 6 and 12.

  7. Change From Baseline in Central Retinal Thickness of the Study Eye Over Time

    Time frame: Baseline, Month 3, Month 6 and Month 12

    Retinal thickness was measured by Central Reading Center using patient's Optical Coherence Tomography (OCT) images provided by investigators.

  8. Percentage of Patients With Choroidal Neovascularization (CNV) Leakage in the Study Eye

    Time frame: Baseline and Month 12

    CNV leakage assessment plus other choroid and retinal disorders were assessed by Central Reading Center using patient's fluorescein angiography and color fundus photography images provided by investigators.

  9. Number of Ranibizumab Injections Received Prior to Month 3

    Time frame: Day 1 and prior to month 3

    In order to describe exposure to the study drug the number of ejections was evaluated

  10. Number of Ranibizumab Injections Received by Patients Randomized to the Ranibizumab Groups, by Period

    Time frame: Day 1 prior to month 6 and prior to month 12

    Number of ranibizumab injections received by patients randomized to the ranibizumab groups, by period

  11. Number of Ranibizumab Injections Received by Patients Randomized to vPDT With Ranibizumab From Month 3 by Period

    Time frame: Month 3 up to month 12

    Number of ranibizumab injections received by patients randomized to the vPDT with ranibizumab groups, by period.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A 12 Month, Phase III, Randomized, Double-masked, Multicenter, Active-controlled Study to Evaluate the Efficacy and Safety of Two Different Dosing Regimens of 0.5 mg Ranibizumab vs. Verteporfin PDT in Patients With Visual Impairment Due to Choroidal Neovascularization Secondary to Pathologic Myopia

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 8, 2010
Registry last updated
Feb 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.