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

This study is currently recruiting participants.
Verified May 2013 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01427751
First received: August 31, 2011
Last updated: May 9, 2013
Last verified: May 2013
History of Changes
  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:

MedlinePlus related topics: Edema
U.S. FDA Resources

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 ]

Estimated Enrollment: 400
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427751

Contacts
Contact: Allergan Inc. clinicaltrials@allergan.com

Locations
France
Recruiting
Paris, France
Germany
Recruiting
Munich, Germany
Israel
Recruiting
Tel Aviv, Israel
Italy
Recruiting
Milan, Italy
Spain
Recruiting
Madrid, Spain
United Kingdom
Recruiting
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: May 9, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular 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
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on May 19, 2013