Back to resultsA Study of RO6867461 Administered in Single- and Multiple-Ascending Doses in Patients With Wet Age-Related Macular Degeneration
Primary Purpose
Macular Degeneration
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
RO6867461
Sponsored by
About this trial
This is an interventional treatment trial for Macular Degeneration
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Part A: RO6867461
Part B: RO6867461
Arm Description
Single doses
Multiple doses
Outcomes
Primary Outcome Measures
Ocular safety, assessed by BCVA (EDTRS chart), slitlamp examination, ophthalmoscopy, IOP, fundus photography, SD-OCT, angiography
Safety: Incidence of adverse events
Secondary Outcome Measures
Pharmacokinetics: Area under the concentration time curve (AUC)
Pharmacokinetics: Maximum plasma concentration (Cmax)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01941082
Brief Title
A Study of RO6867461 Administered in Single- and Multiple-Ascending Doses in Patients With Wet Age-Related Macular Degeneration
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 Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Part A: RO6867461
Arm Type
Experimental
Arm Description
Single doses
Arm Title
Part B: RO6867461
Arm Type
Experimental
Arm Description
Multiple doses
Intervention Type
Drug
Intervention Name(s)
RO6867461
Intervention Description
Single or multiple ascending dose by intravitreal injection
Primary Outcome Measure Information:
Title
Ocular safety, assessed by BCVA (EDTRS chart), slitlamp examination, ophthalmoscopy, IOP, fundus photography, SD-OCT, angiography
Time Frame
Part A, 12 weeks; Part B, 20 weeks
Title
Safety: Incidence of adverse events
Time Frame
Part A, 12 weeks; Part B, 20 weeks
Secondary Outcome Measure Information:
Title
Pharmacokinetics: Area under the concentration time curve (AUC)
Time Frame
Part A, 12 weeks; Part B, 20 weeks
Title
Pharmacokinetics: Maximum plasma concentration (Cmax)
Time Frame
Part A, 12 weeks; Part B, 20 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
City
Bristol
ZIP/Postal Code
BS1 2LX
Country
United Kingdom
City
London
ZIP/Postal Code
EC1V 2PD
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
A Study of RO6867461 Administered in Single- and Multiple-Ascending Doses in Patients With Wet Age-Related Macular Degeneration
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