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

This study is currently recruiting participants.
Verified March 2013 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01396083
First received: July 14, 2011
Last updated: March 28, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Visual Impairment
Macular Edema
Central Retinal Vein Occlusion
 Drug: Ranibizumab
Drug: Dexamethasone implant and 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 Central Retinal Vein Occlusion (CRVO)

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Measure: mean average BCVA change from Month 1 through Month 6 to Baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measure: mean BCVA change at Month 6 [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Measure: percentage of patients gaining / losing ≥ 15 / 10 / 5 letters [ Time Frame: 6 month ] [ Designated as safety issue: No ]
  • Measure: time to achieve a significant improvement ≥ 15 letters [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Measure: change over time of the central retinal thickness [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: August 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranibizumab Drug: Ranibizumab
Active Comparator: Standard of Care Drug: Dexamethasone implant and 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 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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396083

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

  Show 92 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: NCT01396083     History of Changes
Other Study ID Numbers: CRFB002EDE18, 2011-001020-38
Study First Received: July 14, 2011
Last Updated: March 28, 2013
Health Authority: United States: Food and Drug Administration
Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:
Visual impairment
macular edema
Central 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 May 23, 2013