Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions (RADICAL)

NCT00492284 | Completed Phase 2 Results DMC

• 1 other identifier: BPD OCR 022
• Study Type: interventional
• Target: 162
• Locations: 2 countries
• Sites: 26

Brief Summary

The objective of this study is to determine if combination therapy (reduced-fluence Visudyne followed by Lucentis \[within 2 hours\] or either of two regimens of reduced-fluence Visudyne followed by Lucentis-Dexamethasone triple therapy \[within 2 hours\]) reduces retreatment rates compared with Lucentis monotherapy while maintaining similar vision outcomes and an acceptable safety profile.

Conditions

Choroidal Neovascularization; Macular Degeneration

Keywords

Macular Degeneration; AMD; CNV; Choroidal neovascularization; Photodynamic therapy; CNV Secondary to Age Related Macular Degeneration

Outcome Measures

Primary Outcomes (2)

• Mean Number of Retreatments (Day 0 Excluded)

  Retreatment was defined in the protocol as study treatment administered after Day 0. For the analyses of retreatment, any study treatment that was administered was considered to be a retreatment, and combination therapy was considered to be one retreatment, even though two or three treatment procedures were done. In the combination therapy groups, if a ranibizumab injection was given because retreatment was indicated and the previous combination treatment was less than 2 months before, the ranibizumab injection was counted as a retreatment.

  Month 1 to Month 12

• Mean Change From Baseline in Study Eye Best-corrected VA Score (ETDRS Chart)

  Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100

  Baseline to Month 12

Secondary Outcomes (7)

• Mean Number of Retreatments (Day 0 Excluded)

  Month 1 to Month 24

• Mean Change From Baseline in Study Eye Best-Corrected VA Score

  Baseline to Month 24

• Percentage of Subjects With >=15 Letters of Visual Acuity Gained From Baseline

  Baseline to Month 12, Baseline to Month 24

• Percentage of Subjects With >=0 Letter Gain of Visual Acuity From Baseline

  Baseline to Month 12, Baseline to Month 24

• Percentage of Subjects With >=15 Letters of Visual Acuity Lost From Baseline

  Baseline to Month 12, Baseline to Month 24

Study Arms (4)

1/4 Fluence Triple Therapy

EXPERIMENTAL

Very low fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy \[within 2 hours\] administered on Day 0, and then as required every 2 months thereafter

Drug: verteporfin; Drug: ranibizumab; Drug: dexamethasone

1/2 Fluence Triple Therapy

EXPERIMENTAL

Reduced-fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy \[within 2 hours\] administered on Day 0, and then as required every 2 months thereafter

Drug: verteporfin; Drug: ranibizumab; Drug: dexamethasone

1/2 Fluence Double Therapy

EXPERIMENTAL

Reduced-fluence Visudyne followed by Lucentis double therapy \[within 2 hours\] administered on Day 0, and then as required every 2 months thereafter

Drug: verteporfin; Drug: ranibizumab

Ranibizumab

EXPERIMENTAL

Lucentis monotherapy administered on Day 0, Month 1 and Month 2, and then as required monthly thereafter

Drug: ranibizumab

Interventions

verteporfin DRUG

Reduced-fluence Visudyne (25 J/cm2, 300 mW/cm2, 83 seconds)

Also known as: Visudyne, photodynamic therapy

1/2 Fluence Double Therapy; 1/2 Fluence Triple Therapy

ranibizumab DRUG

0.5 mg intravitreal injection

Also known as: Lucentis

1/2 Fluence Double Therapy; 1/2 Fluence Triple Therapy; 1/4 Fluence Triple Therapy; Ranibizumab

dexamethasone DRUG

0.5 mg intravitreal injection

1/2 Fluence Triple Therapy; 1/4 Fluence Triple Therapy

Eligibility Criteria

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

You may qualify if:

• Treatment naive for choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye except for laser treatment outside the subfoveal area
• Subfoveal CNV due to AMD
• CNV must be = or \>50 % of the entire lesion
• All lesion composition types with a lesion greatest linear dimension (GLD) \< 5400 microns (approximately = or \<9 disc areas \[DA\])
• Best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA score) of 25 - 73 letters (approximate Snellen equivalent of 20/40 - 20/320), inclusive

You may not qualify if:

• Subfoveal geographic atrophy or subfoveal fibrosis of the study eye
• Intraocular surgery within 3 months of enrollment
• Inability to attend the protocol-required visits
• Known allergies or hypersensitivity to any of the study treatments.
• Other systemic diseases or active uncontrolled infections that would make subject a poor medical risk
• Uncontrolled glaucoma, defined as (1)subject is on \>1 glaucoma medication (includes combination treatments) or (2)subject has glaucoma that could lead to progressive visual field deterioration
• If subject has had a stroke within the last year

Sponsors & Collaborators

• QLT Inc.: lead

Study Sites (26)

Unknown Facility

Mobile, Alabama, United States

Location

Unknown Facility

Phoenix, Arizona, United States

Location

Retina Centers, PC

Tucson, Arizona, United States

Location

Unknown Facility

Beverly Hills, California, United States

Location

Unknown Facility

Campbell, California, United States

Location

Unknown Facility

Los Angeles, California, United States

Location

Unknown Facility

Poway, California, United States

Location

Unknown Facility

Sacramento, California, United States

Location

Unknown Facility

Torrance, California, United States

Location

Unknown Facility

Fort Myers, Florida, United States

Location

Unknown Facility

Indianapolis, Indiana, United States

Location

Unknown Facility

Davenport, Iowa, United States

Location

Unknown Facility

Missoula, Montana, United States

Location

Unknown Facility

Omaha, Nebraska, United States

Location

Unknown Facility

Portsmouth, New Hampshire, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

West Mifflin, Pennsylvania, United States

Location

Unknown Facility

Arlington, Texas, United States

Location

Unknown Facility

Temple, Texas, United States

Location

Unknown Facility

Seattle, Washington, United States

Location

Unknown Facility

Calgary, Alberta, Canada

Location

Unknown Facility

Vancouver, British Columbia, Canada

Location

Unknown Facility

Halifax, Nova Scotia, Canada

Location

Unknown Facility

London, Ontario, Canada

Location

Unknown Facility

Toronto, Ontario, Canada

Location

MeSH Terms

Conditions

Choroidal Neovascularization; Macular Degeneration

Interventions

Verteporfin; Photochemotherapy; Ranibizumab; Dexamethasone

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)

Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds; Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated

Limitations and Caveats

Retreatment and vision analysis limitations, sample size, lack of standard monotherapy regimen used in practice, no treatment regimen approved by regulatory authorities, potential for bias in FA assessment, no central reading center, single-masked

Results Point of Contact

• Title: Medical Information Department
• Organization: QLT Inc.

medaff@qltinc.com

1-800-663-5486

Study Officials

• Henry Hudson, MD

  Retina Centers, PC

  PRINCIPAL INVESTIGATOR

• Allen Ho, MD

  Retina Diagnostic & Treatment Associates, LLC

  PRINCIPAL INVESTIGATOR

• Andrew Strong, Ph.D

  QLT Inc.

  STUDY CHAIR

• Oscar Cuzzani, MD

  QLT Inc.

  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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 27, 2007
• Study Start: July 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2010
• Last Updated: June 2, 2011
• Results First Posted: June 22, 2010

Record last verified: 2011-05

Locations

US (21); CA (5)