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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Macular Degeneration

Intervention / Treatment
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* Drug: RO6867461


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Part A: RO6867461<br>Single doses | Drug: RO6867461<br>* Single or multiple ascending dose by intravitreal injection<br>|
| Experimental: Part B: RO6867461<br>Multiple doses | Drug: RO6867461<br>* Single or multiple ascending dose by intravitreal injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 |