Efficacy and Safety of Ranibizumab Intravitreal Injections Versus Dexamethasone Intravitreal Implant in Patients With Branch Retinal Vein Occlusion (BRVO) (COMRADE-B)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01396057
First received: July 14, 2011
Last updated: June 13, 2014
Last verified: June 2014
  Purpose

This clinical trial is designed to compare ranibizumab in comparison with Dexamethasone implant after 6 months of treatment. In the study arm Ranibizumab 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.


Condition Intervention Phase
Visual Impairment
Macular Edema
Branch Retinal Vein Occlusion
Drug: Ranibizumad
Other: Dexametha sone Implant + sham injections
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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 Branch Retinal Vein Occlusion (BRVO)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Mean Average Best Corrected Visual Acuity (BCVA) Change From Month 1 Through Month 6 to Baseline [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Mean BCVA Change From Baseline to Endpoints Month 1 to Month 6 [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
    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

  • Percentage of Patients Gaining / Losing ≥ 15 / 10 / 5 Letters After 6 Month Treatment [ Time Frame: 6 month ] [ Designated as safety issue: No ]
    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 15, 10 or 5 more letters of visual acuity at month 6 as compared with baseline

  • Time to Achieve a Significant Improvement ≥ 15 Letters [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
    The time was analyzed by the Kaplan-Maier-Method, adjusting the calculation for dropouts

  • Change Over Time in BCVA [ Time Frame: baseline, month 6 ] [ Designated as safety issue: No ]
    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

  • Change Over Time of the Central Retinal Thickness (CRT) [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
    Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation

  • Changes in the Quality of Life According to the National Eye Institute Visual Function Questionnaire (NEI-VFQ 25) Questionnaires [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
    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.

  • Changes in the Quality of Life According to the Short Form (36) Health Survey (SF-36)Questionnaires [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
    SF-36 summary measures are norm-based scores with mean = 50 and SD = 10. Higher scores indicate better health

  • Changes in the Quality of Life According to Euro Quality of Life (EQ-5D) Questionnaires [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: No ]
    The EQ-5D visual analog scale ranges from 0 to 100, 0 representing the worst and 100 the best imaginable health state.

  • Rate of the Internal Ocular Pressure (IOP) [ Time Frame: Baseline, month 6 ] [ Designated as safety issue: Yes ]
    The proportion of patients with ≥ 10% increase in IOP compared to baseline at any post-baseline visit.


Enrollment: 244
Study Start Date: July 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranibizumab PRN Drug: Ranibizumad
Sham Comparator: Standard of Care Other: Dexametha sone Implant + sham injections

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed with visual impairment due to macular edema following BRVO
  • Diagnosis of BRVO 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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396057

  Show 66 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01396057     History of Changes
Other Study ID Numbers: CRFB002EDE17, 2011-001019-30
Study First Received: July 14, 2011
Results First Received: June 13, 2014
Last Updated: June 13, 2014
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:
Visual impairment
macular edema
branch retinal vein occlusion
Dexamethasone implant
Ranibizumab

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Vision, Low
Vision Disorders
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 24, 2014