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OpenTrials
Completed

NCT Number: NCT01846299

To Assess the Efficacy and Safety of Intravitreal Ranibizumab in People With Vision Loss Due to Macular Edema

To evaluate the efficacy and safety of 0.5 mg Ranibizumab intravitreal injections in adult patients with visual impairment due to macular edema (ME).

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Key information

Conditions

Macular Edema (ME) Eye Diseases Macular Degeneration Macular Edema Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Sensation Disorders Signs and Symptoms 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.

Inclusion criteria

  • Diagnosis of active ME secondary to any causes (for adult patients: except diabetic macular edema (DME), age-related macular degeneration (AMD) and retinal vein occlusion (RVO));
  • BCVA must be between ≥ 24 and ≤ 83 letters;
  • Visual loss should be mainly due to the presence of any eligible types of ME.

Exclusion criteria

  • Women of child-bearing potential,
  • Active malignancies;
  • History of stroke less than 6 months prior to screening;
  • Uncontrolled systemic inflammation or infection, related directly to the underlying causal disease of ME;
  • Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
  • Any type of advanced, severe or unstable ocular disease or its reatment;
  • ME with a high likelihood of spontaneous resolution.

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

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.

ranibizumab

Drug

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

Primary outcomes

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

    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. 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. 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 wasassessed 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: 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 or Absence of Intra-retinal Fluid in Study Eye Compared to Baseline

    Time frame: Month 2, Month 6, Month 12

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

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

    Time frame: Month 2, Month 6, Month 12

    The presence of subretinal fluid was assessed by OCT.

  6. Number of Participants With Presence of Active Macular Edema (ME) Leakage

    Time frame: Month 2

    The presence of active ME leakage was assessed by fluorescein angiography (FA).

  7. Number of Participants Requiring 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.

  8. 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. A positive change from baseline indicated improvement.

  9. 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.

  10. 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.

  11. Number of Participants With Ranibizumab Treatments

    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 6, 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: 12 months

    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 Intravtitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF)Driven Macular Edema

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 3, 2013
Registry last updated
May 23, 2016

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.

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