NCT00464347

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 23, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

March 24, 2010

Status Verified

October 1, 2007

First QC Date

April 19, 2007

Last Update Submit

March 23, 2010

Conditions

Age-Related Macular Degeneration

Keywords

AMDwet AMDverteporfin PDTAvastinTAC-PF

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (12)

  • 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.

  • +7 more secondary outcomes

Interventions

AvastinDRUG
Photodynamic Therapy (PDT)PROCEDURE
Preservative-Free Triamcinolone Acetonide (TAC-PF)DRUG

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • Oral steroid use within 6 months
  • Prior complications from steroid therapy
  • Prior stroke, myocardial infarction, or end-stage malignancy
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Retinal Group of Florida

Fort Lauderdale, Florida, 33334, United States

Location

Central Florida Retina- Orlando

Orlando, Florida, 32746, United States

Location

Retina Specialists

Pensacola, Florida, 32503, United States

Location

Elman Retina Group- Baltimore

Baltimore, Maryland, 21237, United States

Location

Associated Retinal Consulants

Grand Rapids, Michigan, 49546, United States

Location

VitroRetinal Surgery

Minneapolis, Minnesota, 55435, United States

Location

Duke University Eye Center

Durham, North Carolina, 27710, United States

Location

Palmetto Retina Center

Columbia, South Carolina, 29204, United States

Location

Southeastern Retina Associates

Knoxville, Tennessee, 37909, United States

Location

Texas Retina Associates-Arlington

Arlington, Texas, 76012, United States

Location

Texas Retina Associates-Dallas

Dallas, Texas, 85231, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

BevacizumabPhotochemotherapy

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsCombined Modality TherapyTherapeuticsDrug TherapyPhototherapy

Study Officials

  • Karl G Csaky, MD, PhD

    Duke University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

April 19, 2007

First Posted

April 23, 2007

Study Start

January 1, 2007

Study Completion

September 1, 2007

Last Updated

March 24, 2010

Record last verified: 2007-10

Locations

US(11)