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Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01427751
First received: August 31, 2011
Last updated: November 17, 2014
Last verified: November 2014
  Purpose

This study will evaluate the safety and efficacy of dexamethasone intravitreal implant (Ozurdex®) compared to ranibizumab (Lucentis®) in patients with branch retinal vein occlusion (BRVO).


Condition Intervention Phase
Retinal Vein Occlusion
Macular Edema
Drug: dexamethasone intravitreal implant
Biological: ranibizumab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change from Baseline in Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT) [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
  • Percentage of Patients with 15-or-More-Letter Improvement in BCVA [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Percentage of Patients with 15-or-More-Letter Decrease in BCVA [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]

Enrollment: 307
Study Start Date: September 2011
Study Completion Date: November 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ozurdex®
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter.
Drug: dexamethasone intravitreal implant
Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter.
Other Name: Ozurdex®
Active Comparator: Lucentis®
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria.
Biological: ranibizumab
Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria.
Other Name: Lucentis®

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of branch retinal vein occlusion in at least one eye
  • Visual acuity between 20/400 to 20/40

Exclusion Criteria:

  • Active eye infection
  • Ocular hypertension which is not controlled on monotherapy (one medication)
  • Anticipated need for eye surgery during the study
  • Cataract surgery in either eye within 3 months
  • Eye surgery including laser of any type within 6 months
  • Anti-VEGF treatment in either eye (eg, Lucentis®) within 3 months or systemic anti-VEGF treatment (eg, Avastin) within 6 months
  • Use of ocular steroids within 3 months
  • Use of steroids (except for inhaled or intranasal) within 1 month or anticipated use during the study
  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: NCT01427751

Locations
France
Paris, France
Germany
Munich, Germany
Israel
Tel Aviv, Israel
Italy
Milan, Italy
Spain
Madrid, Spain
United Kingdom
London, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01427751     History of Changes
Other Study ID Numbers: MAF-AGN-OPH-RET-004, 2010-023900-29
Study First Received: August 31, 2011
Last Updated: November 17, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Macular Edema
Retinal Vein Occlusion
Cardiovascular Diseases
Embolism and Thrombosis
Eye Diseases
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Thrombosis
Vascular Diseases
Venous Thrombosis
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Central Nervous System Agents
Enzyme Inhibitors
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014