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CompletedNCT00523406Updated May 3, 2013

Comparison of Reduced Fluence Versus Standard Photodynamic Therapy (in Combination With Intravitreal Triamcinolone Acetate)

A Phase 3 interventional study of Photodynamic therapy and intravitreal triamcinolone in Macular Degeneration, sponsored by Medical University of Vienna. Completed at 1 site in Austria. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2013-05-03.

Sponsored by Medical University of Vienna · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
50 Years to 90 Years
Sex
All
01

Study summary

To assess the CNV treatment effect of PDT with verteporfin in combination with IVTA using reduced fluence compared to the standard fluence.

Read the 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.

02

Conditions studied

  • Macular Degeneration

Keywords

  • choroidal neovascularisation,
  • vision,
  • macula,
  • macular degeneration
  • optical coherence tomography
  • neovascular age related macular degeneration
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 40 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Medical University of Vienna is the lead sponsor of 1,076 studies on the registry; 177 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    A

    standard fluence photodynamic therapy and intravitreal triamcinolone combination

    Procedure: Photodynamic therapy and intravitreal triamcinolone

  • Active comparator
    B

    reduced fluence photodynamic therapy and intravitreal triamcinolone combination

    Procedure: Photodynamic therapy and intravitreal triamcinolone

Interventions

  • ProcedurePhotodynamic therapy and intravitreal triamcinolone

    combination of photodynamic therapy and intravitreal triamcinolone combination to treat neovascular AMD

06

What researchers measure

Primary outcomes

  1. • Chorioretinal perfusion. • Perfusion of the neovascular net (CNV). • Changes of intraretinal morphologies. • Central visual function.

    Time frame: one year

Secondary outcomes

  1. macular sensitivity, three dimensional optical coherence tomography

    Time frame: one year

07

Study locations

1 site
  • Medical University of Vienna, Department of Ophthalmology
    Vienna, 1090, Austria
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 3, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00523406
Lead sponsor
Medical University of Vienna
Responsible party
Stefan Sacu (Assoc. Prof. PD Dr., Medical University of Vienna) — Principal investigator
First posted
Aug 31, 2007
Start date
Aug 2005
Primary completion
Jan 2008
Completion
Jan 2008
Last update
May 3, 2013

Study contacts

Ursula Schmidt-Erfurth, MD, Prof.
principal investigator · Department of Ophthalmology, MUVienna

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.

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