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

This study has been completed.
Sponsor:
Information provided by:
QLT Inc.
ClinicalTrials.gov Identifier:
NCT00492284
First received: June 25, 2007
Last updated: May 31, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Choroidal Neovascularization
Macular Degeneration
Drug: verteporfin
Drug: ranibizumab
Drug: dexamethasone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Single-masked Study Comparing Reduced-fluence Visudyne®-Lucentis® Combination Therapies and Lucentis® Monotherapy in Subjects With Choroidal Neovascularization (CNV) Secondary to AMD.

Resource links provided by NLM:


Further study details as provided by QLT Inc.:

Primary Outcome Measures:
  • Mean Number of Retreatments (Day 0 Excluded) [ Time Frame: Month 1 to Month 12 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Study Eye Best-corrected VA Score (ETDRS Chart) [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
    Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100


Secondary Outcome Measures:
  • Mean Number of Retreatments (Day 0 Excluded) [ Time Frame: Month 1 to Month 24 ] [ Designated as safety issue: No ]
    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.

  • Mean Change From Baseline in Study Eye Best-Corrected VA Score [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    Early Treatment Diabetic Retinopathy Study (ETDRS) method at 4 meters. Worst = 0; best = 100

  • Percentage of Subjects With >=15 Letters of Visual Acuity Gained From Baseline [ Time Frame: Baseline to Month 12, Baseline to Month 24 ] [ Designated as safety issue: No ]
  • Percentage of Subjects With >=0 Letter Gain of Visual Acuity From Baseline [ Time Frame: Baseline to Month 12, Baseline to Month 24 ] [ Designated as safety issue: No ]
  • Percentage of Subjects With >=15 Letters of Visual Acuity Lost From Baseline [ Time Frame: Baseline to Month 12, Baseline to Month 24 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Central Retinal Thickness [ Time Frame: Baseline to Month 12, Baseline to Month 24 ] [ Designated as safety issue: No ]
  • Mean Change From Baseline in Lesion Size [ Time Frame: Baseline to Month 12, Baseline to Month 24 ] [ Designated as safety issue: No ]
    Mean change from baseline in lesion size measured as greatest linear dimension (GLD) of the lesion


Enrollment: 162
Study Start Date: July 2007
Study Completion Date: May 2010
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1/4 Fluence Triple Therapy
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
Very-low fluence Visudyne (15 J/cm2, 180 mW/cm2, 83 seconds)
Other Names:
  • Visudyne
  • photodynamic therapy
Drug: ranibizumab
0.5 mg intravitreal injection
Other Name: Lucentis
Drug: dexamethasone
0.5 mg intravitreal injection
Experimental: 1/2 Fluence Triple Therapy
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
Reduced-fluence Visudyne (25 J/cm2, 300 mW/cm2, 83 seconds)
Other Names:
  • Visudyne
  • photodynamic therapy
Drug: ranibizumab
0.5 mg intravitreal injection
Other Name: Lucentis
Drug: dexamethasone
0.5 mg intravitreal injection
Experimental: 1/2 Fluence Double Therapy
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
Reduced-fluence Visudyne (25 J/cm2, 300 mW/cm2, 83 seconds)
Other Names:
  • Visudyne
  • photodynamic therapy
Drug: ranibizumab
0.5 mg intravitreal injection
Other Name: Lucentis
Experimental: Ranibizumab
Lucentis monotherapy administered on Day 0, Month 1 and Month 2, and then as required monthly thereafter
Drug: ranibizumab
0.5 mg intravitreal injection
Other Name: Lucentis

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492284

  Show 26 Study Locations
Sponsors and Collaborators
QLT Inc.
Investigators
Principal Investigator: Henry Hudson, MD Retina Centers, PC
Principal Investigator: Allen Ho, MD Retina Diagnostic & Treatment Associates, LLC
Study Chair: Andrew Strong, Ph.D QLT Inc.
Study Director: Oscar Cuzzani, MD QLT Inc.
  More Information

No publications provided

Responsible Party: Dr. Oscar Cuzzani, QLT Inc.
ClinicalTrials.gov Identifier: NCT00492284     History of Changes
Other Study ID Numbers: BPD OCR 022
Study First Received: June 25, 2007
Results First Received: April 13, 2010
Last Updated: May 31, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by QLT Inc.:
Macular Degeneration
AMD
CNV
Choroidal neovascularization
Photodynamic therapy
CNV Secondary to Age Related Macular Degeneration

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Verteporfin
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors

ClinicalTrials.gov processed this record on August 27, 2014