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Completed

NCT Number: NCT01427751

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

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).

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Key information

Conditions

Retinal Vein Occlusion Cardiovascular Diseases Embolism and Thrombosis Eye Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dexamethasone Intravitreal Implant

Drug

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 names: Ozurdex®

ranibizumab

Biological

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 names: Lucentis®

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Allergan

Industry

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Sep 2, 2011
Registry last updated
Apr 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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