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.

A 12 months, prospective, multicenter, open-label, single arm interventional 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.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003333-15-IT

Enrollment

Unknown

Registered

2013-09-20

Start date

2013-11-15

Completion date

Unknown

Last updated

2017-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 16.0 Level: PT Classification code 10064930 Term: Age-related macular degeneration System Organ Class: 10015919 - Eye disorders

Interventions

Trade Name: LUCENTIS*INIET 1FL 2,3 MG/0,23 ML Product Name: Lucentis Pharmaceutical Form: Solution for injection INN or Proposed INN: RANIBIZUMAB CAS Number: 347396-82-1 Concentration unit: mg/ml mill

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
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	—

Measure

Time frame

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

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Countries

Italy

Contacts

Public ContactDrug Regulatory Affairs

NOVARTIS FARMA

info.studiclinici@novartis.com00390296541

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026