Study assessing the safety and tolerability of 0.5 mg ranibizumab in mono/bilateral wet AMD patients in eyes with BCVA below 2/10 and/or second affected eye.

Phase 1

Conditions: Mono/bilateral Wet Age related Macular Degeneration (wAMD) in eyes with Best Corrected Visual Acuity (BCVA) below 2/10 and/or second affected eye .
MedDRA version: 16.0Level: PTClassification code 10064930Term: Age-related macular degenerationSystem Organ Class: 10015919 - Eye disorders
Therapeutic area: Diseases [C] - Eye Diseases [C11]

Registration Number: EUCTR2013-003333-15-IT

Lead Sponsor: OVARTIS FARMA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Male or female patients aged 50 years or above
- Willing and capable to provide informed written consent
- Eye(s) eligible for ranibizumab treatment, with a BCVA below 2/10 due to wet AMD
AND/OR
- Second eye eligible for ranibizumab treatment, with first eye treated (currently or previously) with ranibizumab, whichever BCVA. In bilateral wAMD patients, the second eye can be included only if the first eye has been treated at least 14 days before with ranibizumab
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 1000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2500

Exclusion Criteria

- Active intraocular inflammation (grade trace or above) in either eye
- Any ocular or periocular active infection (current or suspected), e.g. conjunctivitis, keratitis, scleritis, uveitis, endophtalmitis, in either eye
- Risk factors for retinal pigment epithelial tear (including pigment epithelial retinal detachment)
- Ocular disorders that may confound interpretation of results compromise visual acuity or require medical or surgical intervention during the study period including cataract, retinal vascular occlusion, retinal detachment or macular hole
- Uncontrolled glaucoma in either eye (IOP = 30 mmHg on medication or according to investigator’s judgment)
- History of vitrectomy in the study eye
- History of stroke or transient ischemic attack
- Systemic treatment with any VEGF inhibitor in the 90 days prior to study enrollment
- Ocular treatment of the study eye with any anti-angiogenic drugs within 1 month prior to study enrollment
- Any intraocular surgery in the study eye within 28 days prior to enrollment
- Women of childbearing potential UNLESS using effective contraception during treatment
- Pregnant or lactating women
- Simultaneous participation in a study that includes administration of any investigational drug
- Known hypersensitivity to ranibizumab or any component of the ranibizumab formulation
- Inability to comply with study procedures.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the present study is to evaluate the annual incidence of both ocular and systemic drug-related adverse events following ranibizumab treatment in patients diagnosed with wAMD and BCVA <2/10 and/or second eye affected, whichever BCVA reported.;Secondary Objective: - Describe the treatment patterns for ranibizumab in this type of population; estimate the proportion of systemic and ocular AEs stratifying by type of patient; - evaluate the incidence rate of AEs by study drug exposure; - evaluate a carry-over effect of exposure to possible previous treatment(s) on the relationship between the rate of AEs and drug exposure; - and evaluate the incidence of new onset second eye with wet AMD diagnosis in patients currently enrolled with unilateral diagnosis.;Primary end point(s): Annual incidence of both ocular and systemic drug-related adverse events following ranibizumab treatment.;Timepoint(s) of evaluation of this end point: 12 months

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Describe the treatment patterns for ranibizumab in this type of population; estimate the proportion of systemic and ocular AEs stratifying by type of patient; evaluate the incidence rate of AEs by study drug exposure; evaluate a carry-over effect of exposure to possible previous treatment(s) on the relationship between the rate of AEs and drug exposure; and evaluate the incidence of new onset second eye with wet AMD diagnosis in patients currently enrolled with unilateral diagnosis.;Timepoint(s) of evaluation of this end point: 12 months