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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01427751
Recruitment Status : Completed
First Posted : September 2, 2011
Results First Posted : February 15, 2016
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE August 31, 2011
First Posted Date  ICMJE September 2, 2011
Results First Submitted Date  ICMJE November 3, 2015
Results First Posted Date  ICMJE February 15, 2016
Last Update Posted Date April 18, 2019
Actual Study Start Date  ICMJE October 11, 2011
Actual Primary Completion Date November 4, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2016)
Change From Baseline in Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline, Month 12 ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2011)
Change From Baseline in Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline, Month 12 ]
Change History Complete list of historical versions of study NCT01427751 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2016)
  • Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT) [ Time Frame: Baseline, Month 12 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2011)
  • Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT) [ Time Frame: Baseline, Month 12 ]
  • Percentage of Patients with 15-or-More-Letter Improvement in BCVA [ Time Frame: Month 12 ]
  • Percentage of Patients with 15-or-More-Letter Decrease in BCVA [ Time Frame: Month 12 ]
  • Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) [ Time Frame: Baseline, Month 12 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Ozurdex® Compared to Lucentis® in Patients With Branch Retinal Vein Occlusion
Official Title  ICMJE Not Provided
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Retinal Vein Occlusion
  • Macular Edema
Intervention  ICMJE
  • 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®
  • 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®
Study Arms  ICMJE
  • 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.
    Intervention: Drug: dexamethasone intravitreal implant
  • 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.
    Intervention: Biological: ranibizumab
Publications * Bandello F, Augustin A, Tufail A, Leaback R. A 12-month, multicenter, parallel group comparison of dexamethasone intravitreal implant versus ranibizumab in branch retinal vein occlusion. Eur J Ophthalmol. 2018 Nov;28(6):697-705. doi: 10.1177/1120672117750058. Epub 2018 Apr 9.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2014)
307
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2011)
400
Actual Study Completion Date  ICMJE November 4, 2014
Actual Primary Completion Date November 4, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France,   Germany,   Israel,   Italy,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01427751
Other Study ID Numbers  ICMJE MAF-AGN-OPH-RET-004
2010-023900-29 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Allergan
PRS Account Allergan
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP