Comparison of reduced fluence versus standard photodynamic therapy (in combination with intravitreal triamcinolone acetonide):A prospective, randomized, comparative study

• Conditions: Forty patients will be enrolled into two cohorts of 20 patients each. The study population will consist of male and female patients > 50 years of age with subfoveal CNV secondary to AMD.

• Registration Number: EUCTR2005-000776-41-AT
• Lead Sponsor: Department of Ophthalmology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-18
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified