A Study of RO6867461 Administered in Single- and Multiple-Ascending Doses in Patients With Wet Age-Related Macular Degeneration

Phase 1

Completed

• Conditions: Macular Degeneration
• Interventions: Drug: RO6867461

• Registration Number: NCT01941082
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-03
• Study First Submitted QC: 2013-09-12
• Study First Posted: 2013-09-13
• Study Start: 2013-12
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Part A: RO6867461	RO6867461	Single doses
Part B: RO6867461	RO6867461	Multiple doses

Primary Outcome Measures

Name	Time	Method
Safety: Incidence of adverse events	Part A, 12 weeks; Part B, 20 weeks
Ocular safety, assessed by BCVA (EDTRS chart), slitlamp examination, ophthalmoscopy, IOP, fundus photography, SD-OCT, angiography	Part A, 12 weeks; Part B, 20 weeks

Secondary Outcome Measures

Name	Time	Method
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