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Age-Related Macular DegenerationPhase 2NCT00140803

Study Of Combined VISUDYNE Therapy With Kenalog In CNV Secondary To Age-Related Macular Degeneration

A Phase 2 study testing Visudyne and Kenalog in people with Age-Related Macular Degeneration, run by Manhattan Eye, Ear & Throat Hospital at 2 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

To determine whether VISUDYNE therapy in combination with 4 mg intravitreal triamcinolone will reduce the average loss from baseline of best corrected visual acuity (BCVA) as compared with Visudyne therapy without intravitreal triamcinolone at 12 months in subjects with occult subfoveal and minimally classic subfoveal… Read more about this study

Who is it for?
Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for
Age-Related Macular Degeneration
What is being tested?
Visudyne and Kenalog
How many people
106 participants
Where
2 sitesin 2 countries
Study dates
Oct 2003to Jan 2007
Phase
Phase 2
Are there results?
None posted in the registry

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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • • Age 50 years or older
  • Subfoveal CNV secondary to age-related macular degeneration
  • Area of the CNV at least 50% of the area of the total neovascular lesion
  • The lesion is either minimally classic or occult with no classic
  • If the lesion is occult with no classic then subjects must have presumed recent disease progression in the study eye in the judgment of the Investigator and as defined by presence of blood associated with the lesion or vision loss or lesion growth reported or objectively recorded within the preceding 3 months before randomization to treatment
  • Baseline BCVA score between 73 and 19 letters on the ETDRS scale (approximately 20/40 to 20/400)
  • Lesion size < 5400 microns
  • Ability and willingness to provide written informed consent.

Who cannot join

  • Subjects may not be randomized to treatment if they:
  • Have evidence of predominantly classic CNV, clinically significant intraocular inflammation, angioid streaks, presumed ocular histoplasmosis syndrome, axial myopia greater than -6 diopters, or other precursors of choroidal neovascularization
  • Have additional eye disease that compromises the visual acuity of the study eye.
  • Are receiving or require chronic concomitant therapy with systemic or topical ocular corticosteroids or NSAIDS. Chronic concomitant therapy is defined as multiple doses taken daily for 3 or more consecutive days at any time during the course of the 12-month study). A low dose (up to 100 mg po qd) of aspirin (ASA) taken for prophylaxis of MI and/or stroke is permitted during the study.
  • Are using coumadin.
  • Have known hypersensitivity to verteporfin or triamcinolone
Show all 14Show fewer
  • Have CNV that does not involve the geometric center of the foveal avascular zone, as determined by color photography and fluorescein angiography
  • Are unable to be photographed to document CNV, e.g. due to media opacity, allergy to fluorescein dye or lack of venous access
  • Have lens opacities which, in the investigator's opinion, would progress during the course of the study and would affect central vision in the study eye. Such cataracts may be removed at least 2 months before entering the subject in the study
  • Have a history of treatment for CNV, other than confluent laser photocoagulation, in the study eye (e.g., PDT, submacular surgery, radiotherapy or macular scatter "grid" laser photocoagulation
  • Are participating in another clinical trial requiring follow-up examinations or are receiving or have received any experimental treatment for CNV or any other investigational new drug within 12 weeks prior to the start of study treatment
  • Have an intraocular pressure greater than 21 mm Hg on or off medication on entry to the study.
  • Have received prior treatment with another anti-angiogenic compound (e.g., Sandostatin®, LY333531, Macugen, RhuFab, etc.) within 6 months prior to screening
  • Are unwilling or unable to follow or comply with all study-related procedures.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • Manhattan Eye, Ear & Throat Hospital

    New York, New York, 10021

Other trials in United States

Canada1 site

  • Vh/UBC Eye Care Centre

    Vancouver, British Columbia, V5Z 3N9

Other trials in Canada

About this study

Official title: A Randomized, Single-Masked, Multi-Center, Phase 2 Evaluation Of The Effect Of PDT Using Visudyne In Combination With Intravitreal Injection Of Either 0 mg, 1mg or 4mg of Kenalog In Subfoveal Occult & Minimally Classic CNV Secondary To ARMD

To determine whether VISUDYNE therapy in combination with 4 mg intravitreal triamcinolone will reduce the average loss from baseline of best corrected visual acuity (BCVA) as compared with Visudyne therapy without intravitreal triamcinolone at 12 months in subjects with occult subfoveal and minimally classic subfoveal CNV secondary to AMD. The intravitreal triamcinolone will be given as either a 1 mg or 4 mg dose. This study will also evaluate the safety of Visudyne therapy in combination with intravitreal triamcinolone. An interim statistical readout will be performed when the first 60 patients have completed 6 months of follow-up evaluation.

Read the detailed description

This is a randomized, single-masked (VA examiners, angiographic graders), multi-center, Phase 2 study with 3 arms comparing VISUDYNE therapy in combination with intravitreal injection of either a 1 mg or 4 mg of triamcinolone with VISUDYNE therapy without intravitreal triamcinolone in a 1:1:1 ratio.

Re-treatment may be administered at 3 month intervals ( 14 days) if evidence of CNV leakage is detected by fluorescein angiography.

At baseline and at 3 month (+ 14 days) intervals patients will undergo the following assessments: ophthalmic examination, best corrected visual acuity, fluorescein angiography, and color fundus photography. The eligibility criteria for inclusion into the study and re-treatment of patients will be based on fluorescein angiography. Patients receiving treatment at day-1, week-3, and week-6 following the treatment will have best corrected ETDRS visual acuity testing and ophthalmic. Those patients not being re-treated will have will have best corrected ETDRS visual acuity testing and ophthalmic examination at week-6 following the re-treatment evaluation visit.

Adverse events will be assessed throughout the study.

Expected time for recruitment is 6 months; all patients will be followed for the period of 12 months in the study

Being tested
Visudyne, Kenalog
Medical subject headings
Macular Degeneration

What participants receive

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

  • VisudyneDrug

  • KenalogDrug

What is being measured

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

  1. The primary objective of this study is to determine the effect of Visudyne therapy in combination with 4 mg intravitreal triamcinolone on the mean change in BCVA at Month 12.

    Measured: 12 months

Secondary outcomes (6)

  1. • Proportion of patients having a 15 letter (3 lines) loss or more in BCVA

    Measured: 12 months

  2. • Proportion of patients having a 15 letter (3 lines) improvement or more in BCVA

    Measured: 12 months

  3. • Proportion of patients requiring re-treatment at any time during the study

    Measured: 12 months

  4. • The number of re-treatments required

    Measured: 12 months

  5. • Difference in treatment effect between 1 mg and 4 mg of triamcinolone acetonide

    Measured: 12 months

  6. • The change in MNREAD score

    Measured: 12 months

Timeline

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

  1. First posted1 Sep 2005 (estimated)
  2. Study startOct 2003
  3. Study completionJan 2007

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
Single group
Masking
Single blind
Enrolment
106 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00140803
Sponsor's protocol ID
VISTA
Status last verified
Jul 2007
First submitted
30 Aug 2005
Last updated
12 Jul 2007
Results posted
No
Data monitoring committee
Yes
Expanded access
Available

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Visudyne and Kenalog in people with Age-Related Macular Degeneration, run by Manhattan Eye, Ear & Throat Hospital at 2 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 8 inclusion and 14 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 12 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The primary objective of this study is to determine the effect of Visudyne therapy in combination with 4 mg intravitreal triamcinolone on the mean change in BCVA at Month 12. (time frame: 12 months). 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 NCT00140803.

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 12 Jul 2007.

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