Comparison of Reduced Fluence Versus Standard Photodynamic Therapy (in Combination With Intravitreal Triamcinolone Acetate)
Information source: Medical University of Vienna
Information obtained from ClinicalTrials.gov on March 24, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Macular Degeneration
Intervention: Photodynamic therapy and intravitreal triamcinolone (Procedure)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Medical University of Vienna Official(s) and/or principal investigator(s):
Ursula Schmidt-Erfurth, MD, Prof., Principal Investigator, Affiliation: Department of Ophthalmology, MUVienna
Summary
To assess the CNV treatment effect of PDT with verteporfin in combination with IVTA using
reduced fluence compared to the standard fluence.
Clinical Details
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: • Chorioretinal perfusion.
• Perfusion of the neovascular net (CNV).
• Changes of intraretinal morphologies.
• Central visual function.
Secondary outcome: macular sensitivity, three dimensional optical coherence tomography
Detailed description:
Age-related macular degeneration (AMD) is by far the most common disorder in the group of
irreversible causes of visual disability. AMD leads to dysfunction and loss of photoreceptors
in the central retina. Neovascular AMD affects visual function early in the disease process
and severely compromises the highly developed functions of the macula, such as perception of
details, central fixation, color vision, and reading ability. AMD-related visual impairment
is associated with a loss of autonomy and quality of life. Currently, laser photocoagulation,
photodynamic therapy (PDT) with verteporfin usually combined with intravitreal triamcinolone
acetonide (IVTA) are the only proved treatments for subfoveal choroidal neovascularisation
(CNV). Laser photocoagulation is limited to selected cases. Photodynamic therapy using
verteporfin provides very promising data regarding improvement of visual acuity and absence
of fluorescein leakage. PDT was recently successfully combined with an intravitreal injection
of the corticosteroid triamcinolone acetonide. Yet, PDT also leads to damage to surrounding
normal choroidal vessels. A pilot trial comparing low fluence (300 mW/cm²) with standard
fluence (600 mW/cm²) demonstrated a trend for improved outcomes using the low fluence regimen
(VIM study). However, vascular mechanisms and choroidal damage were not examined, and the
study group was too small to evaluate vision outcome parameters. Combined with the IVTA, the
low fluence effects of PDT may be sufficient for CNV occlusion and the physiological choroids
should be spared from any collateral damage. The aim of this study was to compare reduced
fluence with standard fluence PDT using verteporfin and IVTA for CNV secondary to AMD.
Eligibility
Minimum age: 50 Years.
Maximum age: 90 Years.
Gender(s): Both.
Criteria:
Inclusion criteria:
- Patients 50 years of age or greater.
- Patients with subfoveal choroidal neovascularization lesions secondary to AMD.
- CNV lesion in the study eye is ≤ 4 disc areas in greatest linear dimension.
- Patients who have a BCVA score better than 20/400 in the study eye using ETDRS.
- Only one eye will be assessed in the study. If both eyes are eligible, the one with
the worse visual acuity will be selected for treatment and study unless, based on
medical reasons, the investigator deems the other eye the more appropriate candidate
for treatment and study.
Exclusion Criteria:
- Prior treatment in the study eye with verteporfin, external-beam radiation therapy,
subfoveal focal laser photocoagulation, vitrectomy, submacular surgery, or
transpupillary thermotherapy.
- Previous or current intravitreal drug delivery (e. g., intravitreal corticosteroid
injection or device implantation) in the study eye.
- Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within one month
preceding Visit 1.
- History of glaucoma filtration surgery, corneal transplant surgery or extracapsular
extraction of cataract with phacoemulsification within six months preceding Visit 1,
or a history of post-operative complications within the last 12 months preceding Visit
1 in the study eye (uveitis, cyclitis etc.).
- History of uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥
25 mmHg despite treatment with anti-glaucoma mediation).
- Aphakia or absence of the posterior capsule in the study eye.
- Presence of a retinal pigment epithelial tear involving the macula in the study eye.
- Any concurrent intraocular condition in the study eye (e. g., cataract or diabetic
retinopathy) that, in the opinion of the investigator, could either require medical or
surgical intervention during the three-month study period to prevent or treat visual
loss that might result from that condition.
- Active intraocular inflammation (grade trace or above) in the study eye.
- Any active infection involving eyeball adnexa.
- Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole
(Stage 3 or 4) in the study eye.
- Ocular conditions that require chronic concomitant therapy with systemic or topical
ocular corticosteroids. Chronic concomitant therapy is defined as multiple doses taken
daily for three or more consecutive days at any time within six months prior to
screening or during the course of the study.
Locations and Contacts
Medical University of Vienna, Department of Ophthalmology, Vienna 1090, Austria
Additional Information
Starting date: August 2005
Ending date: October 2007
Last updated: August 30, 2007
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