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



Status:Completed
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:50 - Any
Updated:8/3/2016
Start Date:December 2013
End Date:February 2015

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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

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.


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
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