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Completed

NCT Number: NCT00492284

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

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.

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Verteporfin

Drug

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

Other names: Visudyne, photodynamic therapy

ranibizumab

Drug

0.5 mg intravitreal injection

Other names: Lucentis

Dexamethasone

Drug

0.5 mg intravitreal injection

Primary outcomes

  1. Mean Number of Retreatments (Day 0 Excluded)

    Time frame: Month 1 to Month 12

    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.

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

    Time frame: Baseline to Month 12

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

Secondary outcomes

  1. Mean Number of Retreatments (Day 0 Excluded)

    Time frame: Month 1 to Month 24

    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.

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

    Time frame: Baseline to Month 24

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

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

    Time frame: Baseline to Month 12, Baseline to Month 24

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

    Time frame: Baseline to Month 12, Baseline to Month 24

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

    Time frame: Baseline to Month 12, Baseline to Month 24

  6. Mean Change From Baseline in Central Retinal Thickness

    Time frame: Baseline to Month 12, Baseline to Month 24

  7. Mean Change From Baseline in Lesion Size

    Time frame: Baseline to Month 12, Baseline to Month 24

    Mean change from baseline in lesion size measured as greatest linear dimension (GLD) of the lesion

Sponsors and collaborators

Lead sponsor

QLT Inc.

Industry

Registry information

Official study 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.

Acronym: RADICAL

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Jun 27, 2007
Registry last updated
Jun 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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