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: January 19, 2016
Last verified: January 2016
  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 ]
    BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity) A positive change from Baseline (more letters read correctly) indicates improvement.


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 ]
    Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed in the study eye after pupil dilation at Baseline and Month 12. A negative change from Baseline indicates improvement.

  • Percentage of Patients With 15-or-More Letter Improvement in BCVA [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved.

  • Percentage of Patients With a 15-or-More Letter Decrease in BCVA [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity).

  • Time to BCVA Improvement of 15-or-More Letters [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    BCVA was measured in the study eye using an eye chart and was recorded as the number of letters read correctly for a total possible score of 0 to 100. The time in days to BCVA improvement of 15-or-More letters.

  • Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25) [ Time Frame: Baseline, Month 12 ] [ Designated as safety issue: No ]
    The VFQ-25 includes 25 vision-targeted questions plus one general health question which assess visual impairment on functioning and specific aspects of health-related quality of life for a total possible composite score of 0 (worst) to 100 (best functionality). A positive change from Baseline indicates improvement.

  • Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Treatment failure was defined as withdrawal of the participant from treatment or from the study by the investigator before the final visit because of a lack of efficacy.


Enrollment: 307
Study Start Date: October 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   (Adult, Senior)
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

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
Results First Received: November 3, 2015
Last Updated: January 19, 2016
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on July 28, 2016