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Choroidal NeovascularizationPhase 2RADICALNCT00492284

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

A Phase 2 study testing verteporfin, ranibizumab and dexamethasone in people with Choroidal Neovascularization and Macular Degeneration, run by QLT Inc. at 26 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
verteporfin, ranibizumab and dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
162 participants
Where
26 sitesin 2 countries
Study dates
Jul 2007to May 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

26 sites in 2 countries.

26 sites in 2 countries

United States21 sites

  • Study site

    Arlington, Texas

  • Study site

    Beverly Hills, California

  • Study site

    Campbell, California

  • Study site

    Davenport, Iowa

  • Study site

    Fort Myers, Florida

  • Study site

    Indianapolis, Indiana

  • Study site

    Los Angeles, California

  • Study site

    Missoula, Montana

  • Study site

    Mobile, Alabama

  • Study site

    Omaha, Nebraska

  • Study site

    Philadelphia, Pennsylvania

  • Study site

    Phoenix, Arizona

  • Study site

    Portland, Oregon

  • Study site

    Portsmouth, New Hampshire

  • Study site

    Poway, California

  • Study site

    Sacramento, California

  • Study site

    Seattle, Washington

  • Study site

    Temple, Texas

  • Study site

    Torrance, California

  • Retina Centers, PC

    Tucson, Arizona

  • Study site

    West Mifflin, Pennsylvania

Other trials in United States

Canada5 sites

  • Study site

    Calgary, Alberta

  • Study site

    Halifax, Nova Scotia

  • Study site

    London, Ontario

  • Study site

    Toronto, Ontario

  • Study site

    Vancouver, British Columbia

Other trials in Canada

About this study

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.

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.

Being tested
verteporfin, ranibizumab, dexamethasone
Keywords
Macular Degeneration, AMD, CNV, Choroidal neovascularization, Photodynamic therapy, CNV Secondary to Age Related Macular Degeneration
Medical subject headings
Choroidal Neovascularization, Macular Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • verteporfinDrug

    Also called Visudyne, photodynamic therapy

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

  • verteporfinDrug

    Also called Visudyne, photodynamic therapy

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

  • ranibizumabDrug

    Also called Lucentis

    0.5 mg intravitreal injection

  • dexamethasoneDrug

    0.5 mg intravitreal injection

Study groups in NCT00492284
Study groupRoleWhat they receive
1/4 Fluence Triple TherapyExperimentalVery 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
Receives: Drug: verteporfin; Drug: ranibizumab; Drug: dexamethasone
1/2 Fluence Triple TherapyExperimentalReduced-fluence Visudyne followed by intravitreal Lucentis-Dexamethasone triple therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter
Receives: Drug: verteporfin; Drug: ranibizumab; Drug: dexamethasone
1/2 Fluence Double TherapyExperimentalReduced-fluence Visudyne followed by Lucentis double therapy [within 2 hours] administered on Day 0, and then as required every 2 months thereafter
Receives: Drug: verteporfin; Drug: ranibizumab
RanibizumabExperimentalLucentis monotherapy administered on Day 0, Month 1 and Month 2, and then as required monthly thereafter
Receives: Drug: ranibizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Month 1 to Month 12

  2. 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

    Measured: Baseline to Month 12

Secondary outcomes (7)

  1. 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.

    Measured: Month 1 to Month 24

  2. 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

    Measured: Baseline to Month 24

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

    Measured: Baseline to Month 12, Baseline to Month 24

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

    Measured: Baseline to Month 12, Baseline to Month 24

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

    Measured: Baseline to Month 12, Baseline to Month 24

  6. Mean Change From Baseline in Central Retinal Thickness

    Measured: Baseline to Month 12, Baseline to Month 24

  7. Mean Change From Baseline in Lesion Size

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

    Measured: Baseline to Month 12, Baseline to Month 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jun 2007 (estimated)
  2. Study startJul 2007
  3. Primary completionMay 2009
  4. Study completionMay 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00492284
Sponsor's protocol ID
BPD OCR 022
Acronym
RADICAL
Status last verified
May 2011
First submitted
25 Jun 2007
Last updated
2 Jun 2011
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing verteporfin, ranibizumab and dexamethasone in people with Choroidal Neovascularization and Macular Degeneration, run by QLT Inc. at 26 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Jun 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Number of Retreatments (Day 0 Excluded) (time frame: Month 1 to Month 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00492284.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2011.

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