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

History of Changes

Results First Received: April 13, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Outcomes Assessor); Primary Purpose: Treatment
Conditions:	Choroidal Neovascularization Macular Degeneration
Interventions:	Drug: verteporfin Drug: ranibizumab Drug: dexamethasone

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
1/4 Fluence Triple Therapy	Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1/2 Fluence Triple Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1/2 Fluence Double Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
Ranibizumab	Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter

Participant Flow: Overall Study

	1/4 Fluence Triple Therapy	1/2 Fluence Triple Therapy	1/2 Fluence Double Therapy	Ranibizumab
STARTED	39	39	43	41
COMPLETED	38	35	37	31
NOT COMPLETED	1	4	6	10
Adverse Event	0	1	1	2
Lost to Follow-up	0	0	3	1
Death	0	3	2	5
Withdrawal by Subject	1	0	0	2

Baseline Characteristics

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Reporting Groups

	Description
1/4 Fluence Triple Therapy	Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1/2 Fluence Triple Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
1/2 Fluence Double Therapy	Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
Ranibizumab	Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
Total	Total of all reporting groups

Baseline Measures

	1/4 Fluence Triple Therapy	1/2 Fluence Triple Therapy	1/2 Fluence Double Therapy	Ranibizumab	Total
Number of Participants [units: participants]	39	39	43	41	162
Age [units: years] Mean ± Standard Deviation	78 ± 8	78 ± 8	79 ± 6	79 ± 5	79 ± 7
Gender [units: participants]
Female	20	24	23	28	95
Male	19	15	20	13	67
Lesion composition [units: participants]
Minimally classic	6	4	9	8	27
Occult no classic	10	16	20	18	64
Predominantly classic	23	19	14	15	71
Central retinal thickness [units: micron] Mean ± Standard Deviation	318.3 ± 95.9	337.3 ± 106.8	337.3 ± 121.4	311.9 ± 95.5	326.3 ± 105.4
Lesion size (greatest linear dimension) [units: micron] Mean ± Standard Deviation	2778.8 ± 1025.6	2740.1 ± 846.1	2796.1 ± 1122.8	3118.4 ± 1155.7	2860.1 ± 1049.4
Study Eye Best-corrected Visual Acuity Score (ETDRS chart) ^[1] [units: Letters read on ETDRS chart] Mean ± Standard Deviation	58.1 ± 11.8	55.6 ± 11.2	53.3 ± 11.9	56.0 ± 13.1	55.7 ± 12.0

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

Outcome Measures

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1. Primary:

Mean Number of Retreatments (Day 0 Excluded) [ Time Frame: Month 1 to Month 12 ]

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2. Primary:

Mean Change From Baseline in Study Eye Best-corrected VA Score (ETDRS Chart) [ Time Frame: Baseline to Month 12 ]

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3. Secondary:

Mean Number of Retreatments (Day 0 Excluded) [ Time Frame: Month 1 to Month 24 ]

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4. Secondary:

Mean Change From Baseline in Study Eye Best-Corrected VA Score [ Time Frame: Baseline to Month 24 ]

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5. Secondary:

Percentage of Subjects With >=15 Letters of Visual Acuity Gained From Baseline [ Time Frame: Baseline to Month 12, Baseline to Month 24 ]

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6. Secondary:

Percentage of Subjects With >=0 Letter Gain of Visual Acuity From Baseline [ Time Frame: Baseline to Month 12, Baseline to Month 24 ]

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7. Secondary:

Percentage of Subjects With >=15 Letters of Visual Acuity Lost From Baseline [ Time Frame: Baseline to Month 12, Baseline to Month 24 ]

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8. Secondary:

Mean Change From Baseline in Central Retinal Thickness [ Time Frame: Baseline to Month 12, Baseline to Month 24 ]

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9. Secondary:

Mean Change From Baseline in Lesion Size [ Time Frame: Baseline to Month 12, Baseline to Month 24 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Publication materials will be reviewed and commented on by the Sponsor prior to submission for publication; Names of all Investigators and Sponsor representatives responsible for study design and analysis of results will be disclosed in the publication.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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:

Name/Title: Medical Information Department
Organization: QLT Inc.
phone: 1-800-663-5486
e-mail: medaff@qltinc.com

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

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