Management of recurrent or persistent choroidal neovascularization secondary to age-related macular degeneration A prospective, randomized, clinical study

Phase 1

• Conditions: eovascular age-related macular degeneration; MedDRA version: 14.0Level: LLTClassification code 10015902Term: Exudative senile macular degeneration of retinaSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2010-021923-29-AT
• Lead Sponsor: niversitätsklinik für Augenheilkunden und Optometrie, Medizinische Universität Wien

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07-12
• Last Update Posted: 22 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients 50 years of age or older.
• Patients with persistent or recurrence subfoveal CNV lesion secondary to AMD
• Patients who have a BCVA score better than 20/400 in the study eye using ETDRS.
• At least 6 initial intravitreal ranibizumab monotherapy
• The initial intravitreal ranibizumab treatment performed within the last 6 – 12 months.
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 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60

Exclusion Criteria

• Any prior initial intravitreal treatment other than intravitreal ranibizumab.
• 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.
• Other 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