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Completed

NCT Number: NCT01396083

Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Central Retinal Vein Occlusion (CRVO)

This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant® after 6 months of treatment. In the study arm Lucentis will be given monthly in a pro re nata scheme whereas the comparator Dexamethasone implant is given once at Month 0 with sham injections PRN afterwards.

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Key information

Conditions

Visual Impairment Cardiovascular Diseases Central Retinal Vein Occlusion Embolism and Thrombosis Eye Diseases Macular Degeneration Macular Edema Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Sensation Disorders Signs and Symptoms Thrombosis Vascular Diseases Venous Thrombosis Vision Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Leipzig, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with visual impairment due to macular edema following CRVO
  • Diagnosis of CRVO at maximum 6 months prior to Screening
  • BCVA using ETDRS charts of 20/40 to 20/400 in the study eye

Exclusion criteria

  • Media clarity, pupillary dilation and patient cooperation not sufficient for adequate fundus photographs
  • Central retinal thickness (CRT) < 250 µm in the study eye
  • Prior episode of RVO in the study eye
  • Active formation of new vessels in the study eye
  • Anti-VEGF-treatment in the study or the fellow eye 3 months prior to Baseline
  • IOP ≥ 30mmHg or uncontrolled glaucoma; patients may be re-screened after 1 month if they have undergone glaucoma treatment
  • Improvement of > 10 letters on BCVA between Screening and Baseline

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

ranibizumab

Drug

Dexamethasone implant and sham injections

Drug

Primary outcomes

  1. Mean Average BCVA Change From Month 1 Through Month 6 to Baseline

    Time frame: Baseline, month 6

    the average of the changes in BCVA (letters) from baseline to any post-baseline visit, i.e. the mean of six differences to baseline for the six post-baseline visits at month 1 to 6. 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 pproximately 20/20. An increased score indicates improvement in acuity

Secondary outcomes

  1. Mean BCVA Change at Month 6

    Time frame: Baseline, month 6

    The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors

  2. Number of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters

    Time frame: Baseline, 6 month

    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 number of participants who gained 15, 10 or 5 more letters of visual acuity at month 6 as compared with baseline

  3. Time to Achieve a Significant Improvement ≥ 15 Letters

    Time frame: Baseline, month 6

    The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts

  4. Change Over Time in BCVA

    Time frame: Baseline, month 6

    The analysis was performed by an analysis of covariance (ANCOVA) model with average change in BCVA (letters) from Visit 1 through Visit 6 as dependent variable, and with the factors center, treatment and covariate baseline BCVA as predictors

  5. Change Over Time of the Central Retinal Thickness (CRT)

    Time frame: Baseline, month 6

    Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation

  6. Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires

    Time frame: Baseline, month 6

    The VFQ-25 composite and subscale scores range from 0 to 100, a higher score indicating better functioning. The 12 subscales in the VFQ-25 are general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision. The scores on the subscales were added together for a total score, which ranged from 0 to 100. A higher score indicated improvement in quality of life due to vision function

  7. Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires

    Time frame: Baseline, month 6

    SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health

  8. Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires

    Time frame: Baseline, month 6

    The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state.

  9. Increase Rate of the Internal Ocular Pressure (IOP ) : Patients With ≥10% Increase in IOP Compared to Baseline

    Time frame: Baseline, month 6

    The proportion of patients with ≥ 10% increase in Internal Ocular Pressure (IOP) compared to baseline at any post-baseline visit.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A 6-month Multicenter, Randomized, Double-masked Phase IIIb-study Comparing the Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Visual Impairment Due to Macular Edema Following Central Retinal Vein Occlusion (CRVO)

Acronym: COMRADE-C

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Jul 18, 2011
Registry last updated
Sep 27, 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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