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Phase 4 N=936 Treatment

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

Wet Age Related Macular Degeneration

Enrolled (actual)
936
Serious AEs
6.7%
Results posted
Jul 2019
Primary outcome: Primary: Number of Participants With Systemic Drug-related Adverse Events — 3; 0 participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
ranibizumab (Drug)
Age
Adult, Older Adult · 50+ yrs
Sex
All
Sponsor
Novartis Pharmaceuticals
Primary completion
Jun 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With Systemic Drug-related Adverse Events
3; 0
PRIMARY
Number of Eyes With Ocular Drug-related Adverse Events
1; 8
SECONDARY
Overall Number of Ranibizumab Injections
5.97
SECONDARY
Time Interval Between Injections in Bilateral Disease
51.94
SECONDARY
Mean Number of Injections Per Patient
5.97; 5.35; 10.55

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).

Eligibility 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

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01986907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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