Reduced Fluence Visudyne-Anti-VEGF-Dexamethasone In Combination for AMD Lesions (RADICAL) - Clinical Trial for Choroidal Neovascularization | NCT00492284

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Primary Purpose

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

verteporfin

ranibizumab

dexamethasone

About this trial

This is an interventional treatment trial for Choroidal Neovascularization focused on measuring Macular Degeneration, AMD, CNV, Choroidal neovascularization, Photodynamic therapy, CNV Secondary to Age Related Macular Degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Retina Centers, PC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

1/4 Fluence Triple Therapy

1/2 Fluence Triple Therapy

1/2 Fluence Double Therapy

Ranibizumab

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

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.

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

Secondary Outcome Measures

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.

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

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

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

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

Mean Change From Baseline in Central Retinal Thickness

Mean Change From Baseline in Lesion Size

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

Full Information

NCT ID

NCT00492284

First Posted

June 25, 2007

Last Updated

May 31, 2011

Sponsor

QLT Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00492284

Brief Title

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

Acronym

RADICAL

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.

Study Type

Interventional

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

July 2007 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

QLT Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Choroidal Neovascularization, Macular Degeneration

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

162 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1/4 Fluence Triple Therapy

Arm Type

Experimental

Arm Description

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

Arm Title

1/2 Fluence Triple Therapy

Arm Type

Experimental

Arm Description

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

Arm Title

1/2 Fluence Double Therapy

Arm Type

Experimental

Arm Description

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

Arm Title

Ranibizumab

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

verteporfin

Other Intervention Name(s)

Visudyne, photodynamic therapy

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

verteporfin

Other Intervention Name(s)

Visudyne, photodynamic therapy

Intervention Description

Very-low fluence Visudyne (15 J/cm2, 180 mW/cm2, 83 seconds)

Intervention Type

Drug

Intervention Name(s)

ranibizumab

Other Intervention Name(s)

Lucentis

Intervention Description

0.5 mg intravitreal injection

Intervention Type

Drug

Intervention Name(s)

dexamethasone

Intervention Description

0.5 mg intravitreal injection

Primary Outcome Measure Information:

Title

Mean Number of Retreatments (Day 0 Excluded)

Description

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.

Time Frame

Month 1 to Month 12

Title

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

Description

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

Time Frame

Baseline to Month 12

Secondary Outcome Measure Information:

Title

Mean Number of Retreatments (Day 0 Excluded)

Description

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.

Time Frame

Month 1 to Month 24

Title

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

Description

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

Time Frame

Baseline to Month 24

Title

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

Time Frame