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

• Sponsor: Hoffmann-La Roche (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01941082
• Collaborator: (none)
• Enrollment: 24
• Locations: 8
• Arms: 2
• Duration (Months): 14
• Patients Per Site: 3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Degeneration	Drug: RO6867461	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Feb 1, 2015
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Part A: RO6867461 Single doses	Drug: RO6867461; Single or multiple ascending dose by intravitreal injection
Experimental: Part B: RO6867461 Multiple doses	Drug: RO6867461; Single or multiple ascending dose by intravitreal injection

Outcome Measures

Primary Outcome Measures

1. Ocular safety, assessed by BCVA (EDTRS chart), slitlamp examination, ophthalmoscopy, IOP, fundus photography, SD-OCT, angiography [Part A, 12 weeks; Part B, 20 weeks]

2. Safety: Incidence of adverse events [Part A, 12 weeks; Part B, 20 weeks]

Secondary Outcome Measures

1. Pharmacokinetics: Area under the concentration time curve (AUC) [Part A, 12 weeks; Part B, 20 weeks]

2. Pharmacokinetics: Maximum plasma concentration (Cmax) [Part A, 12 weeks; Part B, 20 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Colorado Springs	Colorado	United States	80909
2		Baltimore	Maryland	United States	21287
3		Dallas	Texas	United States	75231
4		Houston	Texas	United States	77030
5		Charlottesville	Virginia	United States	22908
6		Belfast		United Kingdom	BT12 6BA
7		Bristol		United Kingdom	BS1 2LX
8		London		United Kingdom	EC1V 2PD

Sponsors and Collaborators

• Hoffmann-La Roche

Investigators

• Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hoffmann-La Roche
• ClinicalTrials.gov Identifier: NCT01941082
• Other Study ID Numbers: BP28936; 2013-001972-40
• First Posted: Sep 13, 2013
• Last Update Posted: Nov 2, 2016
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Macular Degeneration

Study Results

No Results Posted as of Nov 2, 2016