---
title: TAC-PF, Avastin® in Combination With Photodynamic Therapy to Treat Age Related Macular Degeneration
nct_id: NCT00464347
overall_status: TERMINATED
phase: PHASE2
sponsor: National Eye Institute (NEI)
study_type: INTERVENTIONAL
primary_condition: Age-Related Macular Degeneration
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00464347.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00464347"
ct_last_update_post_date: 2010-03-24
last_seen_at: "2026-05-12T07:30:06.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# TAC-PF, Avastin® in Combination With Photodynamic Therapy to Treat Age Related Macular Degeneration

**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

**NCT ID:** [NCT00464347](https://clinicaltrials.gov/study/NCT00464347)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Study was terminated because of poor enrollment.
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 100
- **Lead Sponsor:** National Eye Institute (NEI)
- **Collaborators:** QLT Inc.
- **Conditions:** Age-Related Macular Degeneration
- **Start Date:** 2007-01
- **Completion Date:** 2007-09
- **CT.gov Last Update:** 2010-03-24

## 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.

## 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.

## Eligibility

- **Minimum age:** 50 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Interventions

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

## Primary Outcomes

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

## Secondary Outcomes

- **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.**

## Locations (11)

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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.retinal group of florida|fort lauderdale|florida|united states` — added _(2026-05-12)_
- `locations.central florida retina- orlando|orlando|florida|united states` — added _(2026-05-12)_
- `locations.retina specialists|pensacola|florida|united states` — added _(2026-05-12)_
- `locations.elman retina group- baltimore|baltimore|maryland|united states` — added _(2026-05-12)_
- `locations.associated retinal consulants|grand rapids|michigan|united states` — added _(2026-05-12)_
- `locations.vitroretinal surgery|minneapolis|minnesota|united states` — added _(2026-05-12)_
- `locations.duke university eye center|durham|north carolina|united states` — added _(2026-05-12)_
- `locations.palmetto retina center|columbia|south carolina|united states` — added _(2026-05-12)_
- `locations.southeastern retina associates|knoxville|tennessee|united states` — added _(2026-05-12)_
- `locations.texas retina associates-arlington|arlington|texas|united states` — added _(2026-05-12)_
- `locations.texas retina associates-dallas|dallas|texas|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00464347.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00464347*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*