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)

NCT00511706 | Completed Phase 2 Results

• 1 other identifier: 206207-016
• Study Type: interventional
• Target: 243
• Locations: 9 countries
• Sites: 9

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.

Conditions

Choroidal Neovascularization; Age-Related Maculopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change From Baseline in the Best Corrected Visual Acuity (BCVA) at Week 25

  Baseline, Week 25

• 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

• 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

Study Arms (2)

dexamethasone and ranibizumab

EXPERIMENTAL

Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.

Drug: dexamethasone; Biological: ranibizumab

sham and ranibizumab

SHAM COMPARATOR

Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.

Biological: ranibizumab; Other: sham

Interventions

dexamethasone DRUG

Intravitreal injection of dexamethasone 700 µg at Day 1.

Also known as: Posurdex

dexamethasone and ranibizumab

ranibizumab BIOLOGICAL

Ranibizumab 500 µg at day -30 and Day 7-14.

Also known as: Lucentis®

dexamethasone and ranibizumab; sham and ranibizumab

sham OTHER

Sham needle-less injection administered in the study eye at Day 1.

sham and ranibizumab

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Allergan: lead

Study Sites (9)

Unknown Facility

Boynton Beach, Florida, United States

Location

Unknown Facility

Parramatta, New South Wales, Australia

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Tel Aviv, Israel

Location

Unknown Facility

Milan, Italy

Location

Unknown Facility

Auckland, New Zealand

Location

Unknown Facility

Coimbra, Portugal

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Southampton, Hampshire, United Kingdom

Location

Related 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(R) 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.

  PMID: 26088793 BACKGROUND

MeSH Terms

Conditions

Choroidal Neovascularization; Macular Degeneration

Interventions

Dexamethasone; Ranibizumab; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Choroid Diseases; Uveal Diseases; Eye Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Retinal Degeneration; Retinal Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Therapeutic Area Head,
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

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 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2007
• First Posted: August 6, 2007
• Study Start: November 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: April 25, 2019
• Results First Posted: September 3, 2012

Record last verified: 2019-04

Locations

GB (1); AU (1); IL (1); NZ (1); PT (1); FR (1); KR (1); US (1); IT (1)