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)

Choroidal Neovascularization Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00511706
• Other study ID #: 206207-016
• Status: Completed
• Phase: Phase 2
• Start date: November 1, 2007
• Est. completion date: March 1, 2009

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: March 1, 2009
• Est. primary completion date: March 1, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-Related Maculopathy
• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

Drug:
• dexamethasone
Intravitreal injection of dexamethasone 700 µg at Day 1.

Biological:
• ranibizumab
Ranibizumab 500 µg at day -30 and Day 7-14.

Other:
• sham
Sham needle-less injection administered in the study eye at Day 1.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Allergan

Countries where clinical trial is conducted

United States,  Australia,  France,  Israel,  Italy,  Korea, Republic of,  New Zealand,  Portugal,  United Kingdom, 

References & Publications (1)

Kuppermann BD, Goldstein M, Maturi RK, Pollack A, Singer M, Tufail A, Weinberger D, Li XY, Liu CC, Lou J, Whitcup SM; Ozurdex® ERIE Study Group. Dexamethasone Intravitreal Implant as Adjunctive Therapy to Ranibizumab in Neovascular Age-Related Macular Degeneration: A Multicenter Randomized Controlled Trial. Ophthalmologica. 2015;234(1):40-54. doi: 10.1159/000381865. Epub 2015 Jun 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Injection Free Interval	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.	Week 1 to Week 25
Secondary	Change From Baseline in the Best Corrected Visual Acuity (BCVA) at 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.	Baseline, Week 25
Secondary	Change From Baseline in the Mean Central Retinal Subfield Thickness at Week 25 as Assessed by Optical Coherence Tomography (OCT) in the Study Eye	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.	Baseline, Week 25
Secondary	Change From Screening in the Area of Leakage From Choroidal Neovascularization (CNV) at Week 25 as Assessed by Fluorescein Angiography in the Study Eye	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.	Screening (-Week 28), Week 25