Open-label, Multicenter, Phase II Study Assessing the Safety of Lucentis (ranibizumab) Administered in Conjunction with Photodynamic Therapy with Visudyne in Patients with Occult or Predominantly Classic Subfoveal Choroidal Neovascularization Secondary to Age-Related Macular Degeneratio

• Conditions: Male and female patients > 50 years of age with subfoveal choroidal neovascularization (CNV) secondary to AMD.; MedDRA version: 7.0Level: LLTClassification code 10060837

• Registration Number: EUCTR2004-001453-28-AT
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10-15
• Last Update Posted: 22 April 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

• Patients who have a BCVA of < 33 letters (approximately 20/200) in both eyes
• 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 Day 1
• 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 qd for prophylaxis of MI and/or stroke is
permitted during study
• Current use or of likely need for systemic medications known to be toxic to the
lens, retina or optic nerve, including Deferoxamine, Chloroquine/
hydroxychloroquine (Plaquenil), Tamoxifen, Phenothiazines and Ethambuto 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 anti-glaucoma mediation).
• History of submacular surgery or other surgical intervention for AMD in the study
eye within two months preceding Day 1
• 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 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