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

NCT00775411 | Completed Phase 2 Results

• 1 other identifier: 206207-019
• Study Type: interventional
• Target: 44
• Locations: 3 countries
• Sites: 3

Brief Summary

The study will evaluate the safety and efficacy of the intravitreal dexamethasone implant as adjunctive therapy to Anti-VEGF treatment in the study eye of treatment naïve subjects with choroidal neovascularization secondary to age-related macular degeneration. Subjects will be followed for 26 weeks.

Conditions

Choroidal Neovascularization; Age-Related Maculopathy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) at Week 4

  Optical Coherence Tomography (OCT), a laser based non-invasive diagnostic system providing high-resolution imaging sections of the retina, was performed on the study eye after pupil dilation at baseline and Week 4.

  Baseline, Week 4

Secondary Outcomes (2)

• Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 26

  Baseline, Week 26

• Percentage of Participants With Fluorescein Leakage Improved, Unchanged and Worsened From Baseline as Assessed by Fluorescein Angiography at Week 26

  Baseline, Week 26

Study Arms (1)

700 µg dexamethasone and ranibizumab

EXPERIMENTAL

700 µg dexamethasone intravitreal injection at Day 1 in the study eye. Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.

Drug: dexamethasone; Biological: ranibizumab

Interventions

dexamethasone DRUG

700 µg dexamethasone intravitreal injection at Day 1 in the study eye.

Also known as: Posurdex

700 µg dexamethasone and ranibizumab

ranibizumab BIOLOGICAL

Ranibizumab injection at Week 2 or 3 per specified criteria and starting at Week 4 at the investigator's discretion in the study eye.

Also known as: Lucentis®

700 µg dexamethasone 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 active subfoveal choroidal neovascularization (CNV) secondary to AMD
• Central retinal thickness ≥ 300 µm
• Visual acuity between 20/400 and 20/32
• Eligible for Anti-VEGF therapy

You may not qualify if:

• Previous treatment for CNV due to AMD
• High eye pressure
• Glaucoma
• Uncontrolled systemic disease
• Known allergy to the study medications
• Recent eye surgery or injections in the eye
• Female subjects that are of childbearing potential

Sponsors & Collaborators

• Allergan: lead

Study Sites (3)

Unknown Facility

San Antonio, Texas, United States

Location

Unknown Facility

Sydney, New South Wales, Australia

Location

Unknown Facility

Manila, Philippines

Location

MeSH Terms

Conditions

Choroidal Neovascularization; Macular Degeneration

Interventions

Dexamethasone; Ranibizumab

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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2008
• First Posted: October 20, 2008
• Study Start: November 1, 2008
• Primary Completion: November 1, 2009
• Study Completion: April 1, 2010
• Last Updated: September 3, 2012
• Results First Posted: September 3, 2012

Record last verified: 2012-08

Locations

PH (1); US (1); AU (1)