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

Roche

Status and phase: Completed; Phase 1

Conditions: Macular Degeneration

Treatments: Drug: RO6867461

Study type: Interventional

Funder types: Industry

Identifiers

NCT01941082

BP28936

2013-001972-40 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Part A: RO6867461

Experimental group

Description:

Single doses

Treatment:

Drug: RO6867461

Part B: RO6867461

Experimental group

Description:

Multiple doses

Treatment:

Drug: RO6867461