Safety and Tolerability of Ranibizumab in Mono/Bilateral Wet Age Related Macular Degeneration (w-AMD) Patients in Eyes With BCVA<2/10 and/or 2nd Affected Eye

Phase 4

Completed

• Conditions: Wet Age Related Macular Degeneration
• Interventions: Drug: ranibizumab

• Registration Number: NCT01986907
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of ranibizumab in patients affected by wet age related macular degeneration (wAMD).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-12
• Study First Submitted QC: 2013-11-12
• Study First Posted: 2013-11-19
• Study Start: 2014-03-04
• Primary Completion: 2016-06-15
• Study Completion: 2016-06-15
• Results First Submitted: 2017-06-15
• Status Verified: 2019-05
• Results First Submitted QC: 2019-05-11
• Last Update Submitted: 2019-05-11
• Results First Posted: 2019-07-19
• Last Update Posted: 2019-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1049

Inclusion Criteria

Not provided

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
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ranibizumab	ranibizumab	Administered as an Intravitreal injection

Primary Outcome Measures

Name	Time	Method
Number of Participants With Systemic Drug-related Adverse Events	Baseline to Month 12	Monitoring and recording all adverse events, including serious adverse events.
Number of Eyes With Ocular Drug-related Adverse Events	Baseline to Month 12	Monitoring and recording all adverse events, including serious adverse events.

Secondary Outcome Measures

Name	Time	Method
Overall Number of Ranibizumab Injections	Baseline to month 12
Time Interval Between Injections in Bilateral Disease	Baseline to month 12	Mean number of days between two consecutive injections per eye
Mean Number of Injections Per Patient	Baseline to month 12	Number of injections per patient

Trial Locations

Locations (1)

Novartis Investigative Site; 🇮🇹 Pozzuoli, Italy