A 12-month study to evaluate the efficacy and safety of injections of 0.5 mg ranibizumab into the eye of patients with impaired vision which is caused by new vessels (neovascularization) in the choroid and for which ranibizumab may have a positive impact

• Conditions: Visual impairment due to vascular endothelial growth factor (VEGF) driven choroidal neovascularization (CNV); MedDRA version: 16.0Level: LLTClassification code 10060837Term: Choroidal neovascularizationSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 16.0Level: PTClassification code 10047571Term: Visual impairmentSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-005417-38-LV
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-31
• Last Update Posted: 22 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

1. Diagnosis of treatment naïve active CNV secondary to any causes, except wAMD and PM in adults;
2. All types of CNV lesions present in the study eye;
3. BCVA must be between = 24 and = 83 letters in the study eye tested at 4 meters starting distance using ETDRS-like visual acuity charts;
4. Visual loss in the study eye should only be due to the presence of any eligible types of CNV based on ocular clinical, as well as FA and OCT images.

Are the trial subjects under 18? yes
Number of subjects for this age range: 10
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 157
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment;
2. History of malignancy of any organ system within the past 5 years;
3. History of stroke less than 6 months prior to screening;
4. Active systemic inflammation or infection, related directly
to the underlying causal disease of CNV at screening;
5. Active diabetic retinopathy, active ocular/periocular infectious disease or active intraocular inflammation at screening
6. Confirmed intraocular pressure = 25 mmHg for any reason at screening
7. Neovascularization of the iris or neovascular glaucoma at screening
8. CNV secondary to PM or wAMD
9. Use of any systemic anti-VEGF drugs within 6 months before baseline;
10. History of focal laser photocoagulation with involvement of the macular area
administered to treat CNV at any time;
11. History of intraocular treatment with any anti-angiogenic drugs or
verteporfin photodynamic therapy at any time;
12. History of intravitreal treatment with corticosteroids at any time;
13. History of vitreoretinal surgery at any time. Other
protocol-defined inclusion/exclusion criteria may apply.

Study & Design

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