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Macular DegenerationPhase 3NCT00436553

Efficacy/Safety of Verteporfin Photodynamic Therapy and Ranibizumab Compared With Ranibizumab in Patients With Subfoveal Choroidal Neovascularization

A Phase 3 study testing Verteporfin Photodynamic Therapy and Ranibizumab in people with Macular Degeneration and Choroidal Neovascularization, run by Novartis at 43 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

This study evaluated the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration. Read more about this study

Who is it for?
Ages 50 years and older
What is being tested?
Verteporfin Photodynamic Therapy and Ranibizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
321 participants
Where
43 sitesin 2 countries
Study dates
Feb 2007to Oct 2009
Phase
Phase 3
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

  • Subjects of either gender age 50 years or older
  • Subfoveal choroidal neovascularization (CNV) due to age-related macular degeneration (AMD)

Who cannot join

  • Choroidal neovascularization due to causes other than AMD
  • Prior treatment for neovascular AMD in the study eye
  • Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

43 sites in 2 countries.

43 sites in 2 countries

United States36 sites

  • Novartis Investigative Site

    ‘Aiea, Hawaii, 96701

  • Novartis Investigative Site

    Austin, Texas, 78705

  • Novartis Investigative Site

    Baltimore, Maryland, 21205

  • Novartis Investigative Site

    Beachwood, Ohio, 44122

  • Novartis Investigative Site

    Beverly Hills, California, 90211

  • Novartis Investigative Site

    Cincinnati, Ohio, 45242

  • Novartis Investigative Site

    Cleveland, Ohio, 44195

  • Novartis Investigative Site

    Denver, Colorado, 80210

  • Novartis Investigative Site

    Fairfax, Virginia, 22031

  • Novartis Investigative Site

    Grand Rapids, Michigan, 49252

  • Novartis Investigative Site

    Houston, Texas, 77030

  • Novartis Investigative Site

    Independence, Missouri, 64055

  • Novartis Investigative Site

    Iowa City, Iowa, 52242

  • Novartis Investigative Site

    Kingsport, Tennessee, 37660

  • Novartis Investigative Site

    Knoxville, Tennessee, 37909

  • Novartis Investigative Site

    Lexington, Kentucky, 40509

  • Novartis Investigative Site

    Lynbrook, New York, 11563

  • Novartis Investigative Site

    Milwaukee, Wisconsin, 53226

  • Novartis Investigative Site

    Oakland, California, 94609

  • Novartis Investigative Site

    Paducah, Kentucky, 42001

  • Novartis Investigative Site

    Pasadena, California, 91105-3153

  • Novartis Investigative Site

    Pittsburgh, Pennsylvania, 15213

  • Novartis Investigative Site

    Rapid City, South Dakota, 57701

  • Novartis Investigative Site

    Richmond, Virginia, 23226

  • Novartis Investigative Site

    Rochester, New York, 14620

  • Novartis Investigative SIte

    Royal Oak, Michigan, 48073

  • Novartis Investigative Site

    Sacramento, California, 95819

  • West Coast Retina Medical Group Inc. - 185 Berry St. Suite 130

    San Francisco, California, 94107

  • Novartis Investigative Site

    Santa Ana, California, 92705

  • Novartis Investigative Site

    St Louis, Missouri, 63110

  • Novartis Investigative Site

    Toms River, New Jersey, 08755

  • Novartis Investigative Site

    Tucson, Arizona, 85704

  • Novartis Investigative Site

    West Columbia, South Carolina, 29169

  • Novartis Investigative Site

    West Mifflin, Pennsylvania, 15122

  • Novartis Investigative Site

    Wichita, Kansas, 67214

  • Novartis Investigative Site

    Williamsburg, Michigan, 49690

Other trials in United States

Canada7 sites

  • Novartis Investigative Site

    Edmonton, Alberta, T5H OX5

  • Novartis Investigative Site

    Halifax, Nova Scotia, B3H 2Y6

  • Ivey Eye Institute, Dr. Thomas Sheidow

    London, Ontario, N6A 4G5

  • Novartis Investigative Site

    London, Ontario, N6A 4G5

  • Novartis Investigative Site

    Montreal, Quebec, H2L 4MI

  • Novartis Investigative Site

    Ottawa, Ontario, KIH 8L6

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 3N9

Other trials in Canada

About this study

Official title: A 24-month Randomized, Double-masked, Controlled, Multicenter, Phase IIIB Study Assessing Safety and Efficacy of Verteporfin Photodynamic Therapy Administered in Conjunction With Ranibizumab Versus Ranibizumab Monotherapy in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration

This study evaluated the effect of combination therapy with verteporfin photodynamic therapy and ranibizumab on visual acuity and anatomic outcomes compared to ranibizumab monotherapy and the durability of response observed in patients with choroidal neovascularization secondary to age-related macular degeneration.

Being tested
Verteporfin Photodynamic Therapy, Ranibizumab, Verteporfin Placebo, Ranibizumab Placebo
Keywords
Age-related macular degeneration; AMD, choroidal neovascularization, verteporfin, ranibizumab
Medical subject headings
Macular Degeneration, Choroidal Neovascularization

What participants receive

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

  • Verteporfin Photodynamic TherapyDrug

    Also called Visudyne

    After a 10-minute intravenous infusion of verteporfin at a dose of 6 mg/m^2 body surface area, verteporfin was activated by light application of 50 J/cm^2 (Standard Fluence rate) or 25 J/cm^2 (Reduced Fluence rate) to the study eye, begun 15 minutes after the start of the infusion.

  • RanibizumabDrug

    Also called Lucentis

    Ranibizumab 0.5 mg administered as an intravitreal injection.

  • Verteporfin PlaceboDrug

    To maintain masking, as a placebo for verteporfin photodynamic therapy, patients were administered a 10-minute intravenous infusion of 5% dextrose solution, followed by light application of 50 J/cm^2 to the study eye, begun 15 minutes after the start of infusion.

  • Ranibizumab PlaceboDrug

    To maintain masking, patients in the combination groups received sham intravitreal injections whenever retreatment with active Ranibizumab was not warranted based on the retreatment algorithm.

Study groups in NCT00436553
Study groupRoleWhat they receive
Verteporfin With Standard Fluence Rate Plus RanibizumabExperimentalPatients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
Receives: Drug: Verteporfin Photodynamic Therapy; Drug: Ranibizumab; Drug: Ranibizumab Placebo
Ranibizumab MonotherapyActive comparatorPatients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
Receives: Drug: Ranibizumab; Drug: Verteporfin Placebo
Verteporfin With Reduced Fluence Rate Plus RanibizumabExperimentalPatients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
Receives: Drug: Verteporfin Photodynamic Therapy; Drug: Ranibizumab; Drug: Ranibizumab Placebo

What is being measured

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

  1. Mean Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12

    BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An ETDRS visual acuity score of 85 is approximately 20/20. An increase in the VA score indicates improvement in visual acuity.

    Measured: Baseline and Month 12

  2. Percent of Patients With a Treatment-free Interval of at Least 3 Months Following the Month 2 Visit

    The number of patients with a ranibizumab treatment-free interval, ie, no active ranibizumab treatments for at least 3 months duration (at least 2 consecutive monthly visits), anytime following the Month 2 ranibizumab treatment. Only active ranibizumab treatments were considered.

    Measured: Month 2 up to Month 11

Secondary outcomes (3)

  1. Change From Baseline in Total Area of Leakage of the Study Eye at Month 12

    Total area of leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).

    Measured: Baseline and Month 12

  2. Percentage of Patients With Fluorescein Leakage in the Study Eye at Month 12

    The percentage of patients with leakage of the study eye was assessed at the Central Reading Center (CRC) using Fluorescein angiography (FA).

    Measured: Month 12

  3. Change From Baseline in Central Retinal Thickness at Month 12

    Optical coherence tomography was performed in the study eyes and the evaluations of the images were performed by the central reading center.

    Measured: Baseline and Month 12

Timeline

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

  1. First posted19 Feb 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionOct 2009
  4. Study completionOct 2009

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
321 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00436553
Sponsor's protocol ID
CBPD952A2308
Status last verified
Mar 2011
First submitted
16 Feb 2007
Last updated
19 Apr 2011

Publications

  • Kaiser PK, Boyer DS, Cruess AF, Slakter JS, Pilz S, Weisberger A; DENALI Study Group. Verteporfin plus ranibizumab for choroidal neovascularization in age-related macular degeneration: twelve-month results of the DENALI study. Ophthalmology. 2012 May;119(5):1001-10. doi: 10.1016/j.ophtha.2012.02.003. Epub 2012 Mar 22.

    PubMed 22444829

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Verteporfin Photodynamic Therapy and Ranibizumab in people with Macular Degeneration and Choroidal Neovascularization, run by Novartis at 43 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 2 inclusion and 3 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 19 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 19 Apr 2011). 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 Change From Baseline in Best-corrected Visual Acuity (BCVA) of the Study Eye at Month 12 (time frame: Baseline and 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 NCT00436553, which also lists 1 linked publication.

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 19 Apr 2011.

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