Clinical trial NCT00464347: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Age-Related Macular Degeneration
Keywords: AMD
wet AMD
verteporfin PDT
Avastin
TAC-PF
Lead sponsor: National Eye Institute (NEI)
Sponsor class: NIH
Collaborators: name: QLT Inc.
First posted: 2007-04-23
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 criteria: 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

Primary outcomes:
measure: The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to month 12
Secondary outcomes:
measure: Mean and median change in ETDRS BCVA from baseline to months 3, 6, and 24.
measure: Proportion of participants avoiding a loss of ³ 15 letters in ETDRS BCVA by months 3, 6, 12, and 24
measure: Proportion of participants improving by ³ 15 letters in ETDRS BCVA at months 3, 6, 12, and 24.
measure: Proportion of participants who show any improvement in ETDRS BCVA at months 3, 6, 12, and 24.
measure: Mean change in the total lesion area (Disc Areas) from baseline to months 3, 6, 12, and 24.
measure: Mean change in area of CNV (Disc Areas) at months 3, 6, 12, and 24.
measure: Mean change in area of leakage (Disc Areas) at months 3, 6, 12, and 24.
measure: Proportion of classic CNV out of the entire lesion from baseline to months 3, 6, 12, and 24.
measure: Changes in mean excess retinal thickening in the center subfield (i.e., thickness >175 microns) from baseline to months 3, 6, 12, and 24.
measure: 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.
measure: The overall probability of re-injection (excluding injections precluded for safety concerns) through Month 12.
measure: The mean number of injections by quarter on study following initial induction injections.
Other outcomes:
Locations:
city: Ft. Lauderdale
country: United States
facility: Retinal Group of Florida
state: Florida
city: Orlando
country: United States
facility: Central Florida Retina- Orlando
state: Florida
city: Pensacola
country: United States
facility: Retina Specialists
state: Florida
city: Baltimore
country: United States
facility: Elman Retina Group- Baltimore
state: Maryland
city: Grand Rapids
country: United States
facility: Associated Retinal Consulants
state: Michigan
city: Minneapolis
country: United States
facility: VitroRetinal Surgery
state: Minnesota
city: Durham
country: United States
facility: Duke University Eye Center
state: North Carolina
city: Columbia
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Knoxville
country: United States
facility: Southeastern Retina Associates
state: Tennessee
city: Arlington
country: United States
facility: Texas Retina Associates-Arlington
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates-Dallas
state: Texas
Study officials:
affiliation: Duke University
name: Karl G Csaky, MD, PhD
role: STUDY_CHAIR
References: