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

NCT00523406 | Completed Phase 3

• 1 other identifier: EK049/2005
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Macular Degeneration

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  one year

Secondary Outcomes (1)

• macular sensitivity, three dimensional optical coherence tomography

  one year

Study Arms (2)

A

ACTIVE COMPARATOR

standard fluence photodynamic therapy and intravitreal triamcinolone combination

Procedure: Photodynamic therapy and intravitreal triamcinolone

B

ACTIVE COMPARATOR

reduced fluence photodynamic therapy and intravitreal triamcinolone combination

Procedure: Photodynamic therapy and intravitreal triamcinolone

Interventions

Photodynamic therapy and intravitreal triamcinolone PROCEDURE

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

A; B

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Department of Ophthalmology

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Macular Degeneration; Choroidal Neovascularization

Interventions

Photochemotherapy

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Phototherapy

Study Officials

• Ursula Schmidt-Erfurth, MD, Prof.

  Department of Ophthalmology, MUVienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof. PD Dr.

Study Record Dates

• First Submitted: August 29, 2007
• First Posted: August 31, 2007
• Study Start: August 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: May 3, 2013

Record last verified: 2013-05

Locations

AU (1)