Safety and Efficacy of a New Treatment as Adjunctive Therapy to Anti-vascular Endothelial Growth Factor (Anti-VEGF) Treatment in Patients With Age-Related Macular Degeneration (AMD)

Phase 2

Completed

• Conditions: Choroidal Neovascularization; Age-Related Maculopathy
• Interventions: Biological: ranibizumab; Drug: dexamethasone; Other: sham

• Registration Number: NCT00511706
• Lead Sponsor: Allergan

Brief Summary

The study will evaluate the safety and efficacy of the intravitreal implant of dexamethasone with Anti-VEGF treatment vs. Anti-VEGF alone (with sham dexamethasone injection) in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-08-02
• Study First Submitted QC: 2007-08-03
• Study First Posted: 2007-08-06
• Study Start: 2007-11-01
• Primary Completion: 2009-03-01
• Study Completion: 2009-03-01
• Disposition First Submitted: 2010-04-15
• Disposition First Submitted QC: 2010-04-15
• Disposition First Posted: 2010-04-20
• Results First Submitted: 2012-08-01
• Results First Submitted QC: 2012-08-01
• Results First Posted: 2012-09-03
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-11
• Last Update Posted: 2019-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

Inclusion Criteria

• 50 years of age or older with subfoveal choroidal neovascularization (CNV) (classic and/or occult) secondary to AMD
• Visual Acuity between 20/40 and 20/400 in the study eye

Exclusion Criteria

• Any intraocular surgery within 3 months
• Glaucoma
• Cataract
• High eye pressure
• Uncontrolled systemic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sham and ranibizumab	ranibizumab	Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
sham and ranibizumab	sham	Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
dexamethasone and ranibizumab	ranibizumab	Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
dexamethasone and ranibizumab	dexamethasone	Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.

Primary Outcome Measures

Name	Time	Method
Injection Free Interval	Week 1 to Week 25	The injection free interval was defined as the number of days between receiving the second ranibizumab injection (day 7 to 14) to the investigator's determination of eligibility to receive a third ranibizumab injection in the study eye.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25	Baseline, Week 25	BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.
Change From Baseline in the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye	Baseline, Week 25	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 25.
Change From Screening in the Area of Leakage From Choroidal Neovascularization (CNV) at Week 25 as Assessed by Fluorescein Angiography in the Study Eye	Screening (-Week 28), Week 25	Fluorescein angiography (FA) is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc. FA was performed on the study eye after dilation at Screening and Week 25.