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

March 23, 2010 updated by: National Eye Institute (NEI)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Ft. Lauderdale, Florida, United States, 33334
        • Retinal Group of Florida
      • Orlando, Florida, United States, 32746
        • Central Florida Retina- Orlando
      • Pensacola, Florida, United States, 32503
        • Retina Specialists
    • Maryland
      • Baltimore, Maryland, United States, 21237
        • Elman Retina Group- Baltimore
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Associated Retinal Consulants
    • Minnesota
      • Minneapolis, Minnesota, United States, 55435
        • VitroRetinal Surgery
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Eye Center
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Palmetto Retina Center
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Southeastern Retina Associates
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Retina Associates-Arlington
      • Dallas, Texas, United States, 85231
        • Texas Retina Associates-Dallas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria Includes:

  • 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

Exclusion Criteria Includes:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Mean and median change in ETDRS BCVA from baseline to months 3, 6, and 24.
Proportion of participants avoiding a loss of ³ 15 letters in ETDRS BCVA by months 3, 6, 12, and 24
Proportion of participants improving by ³ 15 letters in ETDRS BCVA at months 3, 6, 12, and 24.
Proportion of participants who show any improvement in ETDRS BCVA at months 3, 6, 12, and 24.
Mean change in the total lesion area (Disc Areas) from baseline to months 3, 6, 12, and 24.
Mean change in area of CNV (Disc Areas) at months 3, 6, 12, and 24.
Mean change in area of leakage (Disc Areas) at months 3, 6, 12, and 24.
Proportion of classic CNV out of the entire lesion from baseline to months 3, 6, 12, and 24.
Changes in mean excess retinal thickening in the center subfield (i.e., thickness >175 microns) from baseline to months 3, 6, 12, and 24.
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.
The overall probability of re-injection (excluding injections precluded for safety concerns) through Month 12.
The mean number of injections by quarter on study following initial induction injections.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Eye Institute (NEI)

Collaborators

QLT Inc.

Investigators

  • Study Chair: Karl G Csaky, MD, PhD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

April 19, 2007

First Submitted That Met QC Criteria

April 19, 2007

First Posted (Estimate)

April 23, 2007

Study Record Updates

Last Update Posted (Estimate)

March 24, 2010

Last Update Submitted That Met QC Criteria

March 23, 2010

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-EI-0064

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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