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Age-Related Macular DegenerationPhase 2VERTACLNCT00464347

TAC-PF, Avastin® in Combination With Photodynamic Therapy to Treat Age Related Macular Degeneration

A Phase 2 study testing Avastin, Photodynamic Therapy (PDT) and Preservative-Free Triamcinolone Acetonide (TAC-PF) in people with Age-Related Macular Degeneration, run by National Eye Institute (NEI) at 11 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

VERTACL will investigate whether a triple therapy, Avastin®, half fluence verteporfin photodynamic therapy (PDT), and triamcinolone acetonide-preservative free (TAC- PF), results in improved 12-month vision outcome compared to Avastin® alone in participants with neovascular AMD. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Age-Related Macular Degeneration
What is being tested?
Avastin, Photodynamic Therapy (PDT) and Preservative-Free Triamcinolone Acetonide (TAC-PF)
Type of treatment
Surgery or procedure
How many people
100 participants
Where
11 sitesUnited States
Study dates
Jan 2007to Sep 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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Drusen > 63 mm
  • Choroidal neovascularization under the fovea (Predominantly Classic, Minimally Classic, and Occult lesions acceptable)
  • Greatest linear dimension (GLD) of entire lesion < 5400 µm (no reading center confirmation required)
  • ETDRS best corrected visual acuity of 20/40 - 20/320 (73 - 24 letter score)
  • Total area of lesion must < 9 MPS DA
  • 0-3 intravitreal injections of anti-VEGF monotherapy within 6 months of randomization with continuing evidence of exudative activity confirmed by FA or OCT within 4-8 weeks after the last injection

Who cannot join

  • Oral steroid use within 6 months
  • Prior complications from steroid therapy
  • Prior stroke, myocardial infarction, or end-stage malignancy
  • Study Eye Exclusion Criteria
  • Geographic atrophy or fibrosis under the fovea
  • Fibrosis, hemorrhage, pigment epithelial detachments and other hypofluorescent lesions obscuring more than 50% of total lesion
Show all 12Show fewer
  • Prior treatment with verteporfin within 12 months
  • IOP is >25 mmHg and the participant is on Cosopt
  • Intraocular surgery within 6 weeks
  • Prior vitrectomy
  • Peribulbar steroid injection within 6 months
  • Poor reactions to topical or periocular steroid treatment including elevated IOP

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Texas Retina Associates-Arlington

    Arlington, Texas, 76012

  • Elman Retina Group- Baltimore

    Baltimore, Maryland, 21237

  • Palmetto Retina Center

    Columbia, South Carolina, 29204

  • Texas Retina Associates-Dallas

    Dallas, Texas, 85231

  • Duke University Eye Center

    Durham, North Carolina, 27710

  • Retinal Group of Florida

    Fort Lauderdale, Florida, 33334

  • Associated Retinal Consulants

    Grand Rapids, Michigan, 49546

  • Southeastern Retina Associates

    Knoxville, Tennessee, 37909

  • VitroRetinal Surgery

    Minneapolis, Minnesota, 55435

  • Central Florida Retina- Orlando

    Orlando, Florida, 32746

  • Retina Specialists

    Pensacola, Florida, 32503

Other trials in United States

About this study

Official title: Multi-Center, Randomized, Phase II Clinical Trial to Study the Effects of Preservative-Free Triamcinolone Acetonide and Avastin® in Combination With Photodynamic Therapy in Participants With Neovascular Age Related Macular Degeneration

VERTACL will investigate whether a triple therapy, Avastin®, half fluence verteporfin photodynamic therapy (PDT), and triamcinolone acetonide-preservative free (TAC- PF), results in improved 12-month vision outcome compared to Avastin® alone in participants with neovascular AMD.

Read the detailed description

The VERTACL study is a multi-center, randomized, Phase II trial to investigate whether a triple therapy, Avastin®, half fluence verteporfin PDT, and TAC- PF, results in improved 12-month vision outcome compared to Avastin® alone in participants with neovascular AMD.

Participants will be randomized (similar to the flip of a coin) in a 1:1 ratio to one of the two study groups: single therapy (Avastin®), or triple therapy (Avastin®, half fluence verteporfin PDT, and TAC- PF). Participants in the Avastin® alone arm will receive 1.25 mg intravitreal Avastin®, at every study visit. Participants in the triple-therapy arm will receive all treatments (Avastin®, half fluence verteporfin PDT, and TAC- PF) at baseline.

Following baseline, participants in the triple therapy study arm will receive study treatment on an as-needed (PRN) basis if protocol-specific re-treatment criteria are met. After randomization, participants will return to the clinic approximately every six weeks for one year for study assessments and possible re-treatment.

Participants will return to the clinic at month 24 for a final study assessment. Study assessments include: visual acuity, optical coherence tomography, and fundus photography.

Being tested
Avastin, Photodynamic Therapy (PDT), Preservative-Free Triamcinolone Acetonide (TAC-PF)
Keywords
AMD, wet AMD, verteporfin PDT, Avastin, TAC-PF
Medical subject headings
Macular Degeneration

What participants receive

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

  • AvastinDrug

  • Photodynamic Therapy (PDT)Procedure or surgery

  • Preservative-Free Triamcinolone Acetonide (TAC-PF)Drug

What is being measured

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

  1. The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to month 12

Secondary outcomes (12)

  1. Mean and median change in ETDRS BCVA from baseline to months 3, 6, and 24.

  2. Proportion of participants avoiding a loss of ³ 15 letters in ETDRS BCVA by months 3, 6, 12, and 24

  3. Proportion of participants improving by ³ 15 letters in ETDRS BCVA at months 3, 6, 12, and 24.

  4. Proportion of participants who show any improvement in ETDRS BCVA at months 3, 6, 12, and 24.

  5. Mean change in the total lesion area (Disc Areas) from baseline to months 3, 6, 12, and 24.

  6. Mean change in area of CNV (Disc Areas) at months 3, 6, 12, and 24.

  7. Mean change in area of leakage (Disc Areas) at months 3, 6, 12, and 24.

  8. Proportion of classic CNV out of the entire lesion from baseline to months 3, 6, 12, and 24.

  9. Changes in mean excess retinal thickening in the center subfield (i.e., thickness >175 microns) from baseline to months 3, 6, 12, and 24.

  10. Proportion of participants with reduction in retinal thickening in the center subfield (i.e., thickness > 175 microns) of ³50% and of at least 50 microns from baseline to months 3, 6, 12, and 24.

  11. The overall probability of re-injection (excluding injections precluded for safety concerns) through Month 12.

  12. The mean number of injections by quarter on study following initial induction injections.

Timeline

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

  1. First posted23 Apr 2007 (estimated)
  2. Study startJan 2007
  3. Study completionSep 2007

Why it stopped: Study was terminated because of poor enrollment.

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
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00464347
Sponsor's protocol ID
05-EI-0064
Acronym
VERTACL
Status last verified
Oct 2007
First submitted
19 Apr 2007
Last updated
24 Mar 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Avastin, Photodynamic Therapy (PDT) and Preservative-Free Triamcinolone Acetonide (TAC-PF) in people with Age-Related Macular Degeneration, run by National Eye Institute (NEI) at 11 sites in United States.

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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 24 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. 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 was stopped early (reason given: Study was terminated because of poor enrollment.). Results are not available in the source record.

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 mean change in best-corrected ETDRS visual acuity in the study eye from baseline to month 12. 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 NCT00464347.

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 24 Mar 2010.

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