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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01941082

Enrollment

Registered

2013-09-13

Start date

2013-12-31

Completion date

2015-02-28

Last updated

2016-11-02

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

Conditions

Macular Degeneration

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.

Interventions

DRUGRO6867461

Single or multiple ascending dose by intravitreal injection

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026