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

Macular Edema Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427751
• Other study ID #: MAF-AGN-OPH-RET-004
• Secondary ID: 2010-023900-29
• Status: Completed
• Phase: Phase 4
• Start date: October 11, 2011
• Est. completion date: November 4, 2014

Study information

• Verified date: April 2019
• Source: Allergan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 307
• Est. completion date: November 4, 2014
• Est. primary completion date: November 4, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Edema
• Retinal Vein Occlusion

Intervention

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.

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

France,  Germany,  Israel,  Italy,  Spain,  United Kingdom, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in Central Retinal Subfield Thickness Using Optical Coherence Tomography (OCT)	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.	Baseline, Month 12
Secondary	Percentage of Patients With 15-or-More Letter Improvement in 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). An improvement in the number of letters read means that the vision has improved.	Baseline, Month 12
Secondary	Percentage of Patients With a 15-or-More Letter Decrease in 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).	Baseline, Month 12
Secondary	Time to BCVA Improvement of 15-or-More Letters	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.	12 Months
Secondary	Change From Baseline in National Eye Institute Visual Functioning Questionnaire-25 (VFQ-25)	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.	Baseline, Month 12
Secondary	Percentage of Participants Not Completing the Month 12 Visit Due to Treatment Failure	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.	12 Months