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

NCT01427751 | Completed Phase 4 Results

• 2 other identifiers: MAF-AGN-OPH-RET-0042010-023900-29
• Study Type: interventional
• Target: 307
• Locations: 6 countries
• Sites: 6

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).

Conditions

Retinal Vein Occlusion; Macular Edema

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Best Corrected Visual Acuity (BCVA)

  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.

  Baseline, Month 12

Secondary Outcomes (6)

• Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT)

  Baseline, Month 12

• Percentage of Patients With 15-or-More Letter Improvement in BCVA

  Baseline, Month 12

• Percentage of Patients With a 15-or-More Letter Decrease in BCVA

  Baseline, Month 12

• Time to BCVA Improvement of 15-or-More Letters

  12 Months

• Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)

  Baseline, Month 12

Study Arms (2)

Ozurdex®

ACTIVE COMPARATOR

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

Lucentis®

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Ozurdex®

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.

Also known as: Lucentis®

Lucentis®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (6)

Unknown Facility

Paris, France

Location

Unknown Facility

Munich, Germany

Location

Unknown Facility

Tel Aviv, Israel

Location

Unknown Facility

Milan, Italy

Location

Unknown Facility

Madrid, Spain

Location

Unknown Facility

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 29631435 BACKGROUND

MeSH Terms

Conditions

Retinal Vein Occlusion; Macular Edema

Interventions

Dexamethasone; Calcium Dobesilate; Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Macular Degeneration; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Allergan Inc.,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2011
• First Posted: September 2, 2011
• Study Start: October 11, 2011
• Primary Completion: November 4, 2014
• Study Completion: November 4, 2014
• Last Updated: April 18, 2019
• Results First Posted: February 15, 2016

Record last verified: 2019-04

Locations

IT (1); GB (1); ES (1); DE (1); IL (1); FR (1)