Safety and Efficacy of Dexamethasone as Adjunctive Therapy to Ranibizumab in Subjects With Choroidal Neovascularization and Age-Related Macular Degeneration

NCT01122511 | Terminated Phase 2 Results

• 1 other identifier: 206207-021
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

This study will evaluate the safety and efficacy of dexamethasone (OZURDEX®) as adjunctive therapy to ranibizumab (LUCENTIS®) compared with ranibizumab alone in the treatment of patients with choroidal neovascularization secondary to age-related macular degeneration

Conditions

Subfoveal Choroidal Neovascularization; Age-Related Maculopathy

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Best Corrected Visual Acuity (BCVA) at Month 12

  BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). 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, Month 12

Secondary Outcomes (3)

• The Percentage of Patients Having 15 or More Letter Improvement From Baseline in Best Corrected Visual Acuity at Month 12

  Baseline, Month 12

• Change From Baseline in Central Retinal Thickness at Month 12 as Measured by Optical Coherence Tomography

  Baseline, Month 12

• Change From Baseline in Area Leakage of Choroidal Neovascularization at Month 12 as Measured by Fluorescein Angiography

  Baseline, Month 12

Study Arms (2)

700 ug dexamethasone and ranibizumab

EXPERIMENTAL

Intravitreal injection of 700 ug dexamethasone and ranibizumab into study eye

Drug: 700 ug dexamethasone; Biological: ranibizumab

ranibizumab and sham

ACTIVE COMPARATOR

Intravitreal injection of ranibizumab and Sham into study eye

Biological: ranibizumab; Other: sham

Interventions

700 ug dexamethasone DRUG

Intravitreal injection of 700 ug dexamethasone into study eye

Also known as: OZURDEX®

700 ug dexamethasone and ranibizumab

ranibizumab BIOLOGICAL

Intravitreal injection of ranibizumab into study eye

Also known as: Lucentis®

700 ug dexamethasone and ranibizumab; ranibizumab and sham

sham OTHER

Sham needle-less injection administered in the study eye

ranibizumab and sham

Eligibility Criteria

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

You may qualify if:

• Received at least 2 and no more than 3 monthly Lucentis or Avastin injections
• Last Lucentis or Avastin was injected approximately 4 weeks prior to screening
• Visual acuity between 20/320 and 20/40

You may not qualify if:

• Active ocular infection
• Contraindication to pupil dilation in either eye
• Eye surgery including cataract surgery and/or laser of any type within 3 months

Sponsors & Collaborators

• Allergan: lead

Study Sites (2)

Unknown Facility

Fort Myers, Florida, United States

Location

Unknown Facility

Abilene, Texas, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

Dexamethasone; Calcium Dobesilate; Ranibizumab; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

The study was terminated early due to difficulties with patient recruitment. No participants reached the 12 month time-point. Efficacy analyses were not performed.

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: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: May 13, 2010
• Study Start: August 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: September 5, 2012
• Results First Posted: September 5, 2012

Record last verified: 2012-08

Locations

US (2)