A Multiple-Center, Non-Randomized, Open-Label, Single- and Multiple-Ascending-Dose, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO6867461 Following Intravitreal Administration in Patients With Wet Age-Related Macular Degeneration

Hoffmann-La Roche0 sites24 target enrollmentDecember 2013

ConditionsMacular Degeneration

InterventionsRO6867461

DrugsRO6867461

Overview

Phase: Phase 1
Intervention: RO6867461
Conditions: Macular Degeneration
Sponsor: Hoffmann-La Roche
Enrollment: 24
Primary Endpoint: Safety: Incidence of adverse events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This multicenter, non-randomized, open-label, single- and multiple-ascending-dose study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO6867461 in patients with wet age-related macular degeneration.

Registry

clinicaltrials.gov

Start Date

December 2013

End Date

February 2015

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult patients, \>/= 50 years of age
•Patients with age-related macular degeneration (AMD)
•Best corrected visual acuity (BCVA) of 20/40 to 20/400 (Snellen equivalent, on ETDRA charts) inclusive
•Evidence of leakage due to choroidal neovascularization (CNV)

Exclusion Criteria

•Choroidal neovascularization (CNV) in either eye due to causes other than age related macular degeneration, such as ocular histoplasmosis, trauma, or pathologic myopia
•Known hypersensitivity to ranibizumab, fluorescein, indocyanin green (ICG) or any of the ingredients of the formulation used, or any of the medications used
•Any other restriction according to the use of ranibizumab
•Active intraocular inflammation (grade trace or above) in the study eye
•Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye

Arms & Interventions

Part A: RO6867461

Single doses

Intervention: RO6867461

Part B: RO6867461

Multiple doses

Intervention: RO6867461

Outcomes

Primary Outcomes

Safety: Incidence of adverse events

Time Frame: Part A, 12 weeks; Part B, 20 weeks

Ocular safety, assessed by BCVA (EDTRS chart), slitlamp examination, ophthalmoscopy, IOP, fundus photography, SD-OCT, angiography

Time Frame: Part A, 12 weeks; Part B, 20 weeks

Secondary Outcomes

Pharmacokinetics: Area under the concentration time curve (AUC)(Part A, 12 weeks; Part B, 20 weeks)
Pharmacokinetics: Maximum plasma concentration (Cmax)(Part A, 12 weeks; Part B, 20 weeks)