Initial Combination of Photodynamic Therapy with Verteporfin and Intravitreal Administration of Ranibizumab in Patients with Subfoveal Choroidal Neovascularisation due to Age-related Macular Degeneratio

• Conditions: The case-series is designed to evaluate the safety and efficacy of intravitreal ranibizumab used in combination with verteporfin photodynamic therapy (Visudyne) for the treatment of subfoveal CNV secondary to AMD

• Registration Number: EUCTR2006-004978-27-AT
• Lead Sponsor: Zentralklinikum St. Pölten

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Patients 50 years of age or greater
•Patients with subfoveal choroidal neovascularization lesions secondary to AMD, either predominantly classic, occult, or minimally classic.
•CNV lesion in the study eye is =5400 microns in greatest linear dimension
•Patients who have a best corrected visual acuity (BCVA) score between 73 and 24 letters, inclusively, in the study eye using ETDRS-like grading charts (approximately 20/40 to 20/320) measured at 4 meters
•Willing to return for follow up scheduled visits for a 12 months period
•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) no
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

•Patients who have a BCVA of approximately 20/200 in both eyes
•Prior treatment in the study eye with verteporfin, external-beam radiation therapy, vitrectomy, submacular surgery, other surgical intervention for AMD, or transpupillary thermotherapy
•Previous or current intravitreal drug delivery (e.g., intravitreal corticosteroid injection or device implantation) in the study eye
•Focal laser photocoagulation (juxta-, extra- or subfoveal ) in the study eye
•Concomitant use of chronic NSAIDs or steroids (by any route) for the duration of study participation (chronic use is defined as multiple doses taken daily for three or more consecutive days at any time during the study). Note that ASA (aspirin) taken as low dose” up to 100 mg daily (qd) for prophylaxis of myocardial infarction (MI) and/or stroke is permitted during study
•Current use or likely need for systemic medications known to be toxic to the lens, retina or optic nerve, including Deferoxamine, Chloroquine/ hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambutol is excluded
•History of glaucoma filtration surgery, corneal transplant surgery or extracapsular extraction of cataract with phacoemulsification within six months preceding Day One, or a history of post-operative complications within the last 12 months preceding Day One in the study eye (uveitis, cyclitis etc.)
•History of uncontrolled glaucoma in the study eye (defined as intraocular pressure = 25 mmHg despite treatment with topical anti-glaucomatous medication).
•Aphakia or absence of the posterior capsule in the study eye
•Previous violation of the posterior capsule in the study eye is also excluded unless it occurred as a result of YAG posterior capsulotomy in association with prior, posterior chamber intraocular lens implantation
•Spherical equivalent of the refractive error in the study eye demonstrating more than –8 diopters of myopia
•Presence of a retinal pigment epithelial tear involving the macula in the study eye
•Angioid streaks or precursors of CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia
•Active intraocular inflammation (grade trace or above) in the study eye
•Any active infection involving an eyeball adnexa
•Vitreous hemorrhage or history of rhegmatogenous retinal detachment or macular hole (Stage 3 or 4) in the study eye

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: The case-series is designed to evaluate the safety and efficacy of intravitreal ranibizumab used in combination with verteporfin photodynamic therapy (Visudyne) for the treatment of subfoveal CNV secondary to AMD;Secondary Objective: ;Primary end point(s): Evaluation of changes in visual acuity from baseline at 12 months in patients treated with intravitreal ranibizumab in combination with verteporfin photodynamic therapy