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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00464347
Other study ID # 05-EI-0064
Secondary ID
Status Terminated
Phase Phase 2
First received April 19, 2007
Last updated March 23, 2010
Start date January 2007
Est. completion date September 2007

Study information

Verified date October 2007
Source National Eye Institute (NEI)
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 100
Est. completion date September 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Avastin

Procedure:
Photodynamic Therapy (PDT)

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


Locations

Country Name City State
United States Texas Retina Associates-Arlington Arlington Texas
United States Elman Retina Group- Baltimore Baltimore Maryland
United States Palmetto Retina Center Columbia South Carolina
United States Texas Retina Associates-Dallas Dallas Texas
United States Duke University Eye Center Durham North Carolina
United States Retinal Group of Florida Ft. Lauderdale Florida
United States Associated Retinal Consulants Grand Rapids Michigan
United States Southeastern Retina Associates Knoxville Tennessee
United States VitroRetinal Surgery Minneapolis Minnesota
United States Central Florida Retina- Orlando Orlando Florida
United States Retina Specialists Pensacola Florida

Sponsors (2)

Lead Sponsor Collaborator
National Eye Institute (NEI) QLT Inc.

Country where clinical trial is conducted

United States, 

Outcome

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