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OpenTrials
Completed

NCT Number: NCT01840410

Assess the Efficacy/Safety of Intravitreal Ranibizumab in Patients With Vision Loss Due to Choroidal Neovascularization.

This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult and adolescent patients with visual impairment due to choridal neovascularization (CNV).

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Key information

Conditions

Choroidal Neovascularization (CNV) Choroid Diseases Choroidal Neovascularization Eye Diseases Metaplasia Neovascularization, Pathologic Nervous System Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Uveal Diseases Vision Disorders

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Sydney, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Diagnosis of active CNV secondary to any causes with the CNV or its sequelae affecting the fovea;
  • BCVA must be between ≥ 24 and ≤ 83 letters in the study eye;
  • Visual loss in the study eye should mainly be due to the presence of any eligible types of CNV;

Key Exclusion Criteria:

  • Women of child-bearing potential;
  • Active malignancies;
  • History of stroke less than 6 months prior to screening;
  • Uncontrolled systemic inflammation or infection;
  • Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
  • CNV- conditions with a high likelihood of spontaneous resolution;
  • History of intravitreal treatment with steroids;
  • History of laser photocoagulation;
  • History of intraocular treatment with any anti-angiogenic drugs.

Treatment and study plan

ranibizumab

Drug

Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.

Sham control

Other

The sham vial did not contain active drug (empty sterile vial). The sham injection was an imitation of an intravitreal injection using an injection syringe without a needle touching the eye.

Primary outcomes

  1. Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2

    Time frame: Baseline, Month 2

    BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using mixed model repeated measures (MMRM) which contained scheduled visit, the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate and treatment group by visit and visit by centered baseline BCVA interactions. A positive change from baseline indicated improvement.

Secondary outcomes

  1. Change From Baseline in BCVA in Study Eye up to Month 2

    Time frame: Baseline, Month 1, Month 2

    BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using analysis of covariance (ANCOVA) model which contained the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate. A positive change from baseline indicated improvement.

  2. Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye

    Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

    CSFT was assessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement.

  3. Change From Baseline in Central Subfield Volume (CSFV) in Study Eye

    Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12

    CSFV was assessed OCT. A negative change from baseline indicates improvement.

  4. Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline

    Time frame: Baseline, Month 2, Month 6, Month 12

    The presence of intra-retinal fluid was assessed by OCT.

  5. Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline

    Time frame: Baseline, Month 2, Month 6, Month 12

    Presence of subretinal fluid in study eye compared to baseline

  6. Number of Participants With Presence of Active Chorioretinal Leakage

    Time frame: Baseline, Month 2, Month 6, Month 12

    The presence of active chorioretinal leakage was assessed by photography imaging, i.e. fluorescein angiography (FA).

  7. Average Change From Baseline in BCVA

    Time frame: Baseline (BL), Month 1 through Month 6, Month 1 through Month 12

    BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. BCVA was assessed at each month from Month 1 through Month 6 or at each month from Month 1 through month 12, and the data were averaged. The outcome measure is reporting the change between baseline and average BCVA from Month 1 through Month 6 or from Month 1 through Month 12 (average BCVA - baseline BCVA). A positive change from baseline indicated improvement.

  8. Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters

    Time frame: Month 2, Month 6, Month 12

    VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.

  9. Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss

    Time frame: Month 2, Month 6, Month 12

    VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.

  10. Number of Participants With Requirement for Rescue Treatment at Month 1

    Time frame: Month 1

    Rescue treatment with laser photocoagulation or periocular treatment could be administered at Month 1 only if the participant had a visual acuity loss of > 5 letters due to disease activity from baseline to Month 1.

  11. Number of Participants With Ranibizumab Treatments in Study Eye

    Time frame: Month 12

    The number of participants administered study treatments, according to treatment frequency, was assessed.

  12. Number of Participants With Re-treatments

    Time frame: Month 12

    The number of participants, administered re-treatments according to treatment frequency, was assessed. Re-treatment was defined as an administration of study medication following at least one non-missed visit where treatment was not administered in the study eye. Up to month 12, the maximum number of retreatments was 5.

  13. Number of Primary Reasons for Decision to Treat by Investigator

    Time frame: Month 12

    The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A 12-month, Randomized, Double-masked, Sham-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 0.5mg Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF) Driven Choroidal Neovascularization.

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 25, 2013
Registry last updated
Aug 26, 2016

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

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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.

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