NCT01941082

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2013

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

1.2 years

First QC Date

September 3, 2013

Last Update Submit

November 1, 2016

Conditions

Macular Degeneration

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

Part A: RO6867461

EXPERIMENTAL

Single doses

Drug: RO6867461

Part B: RO6867461

EXPERIMENTAL

Multiple doses

Drug: RO6867461

Interventions

RO6867461DRUG

Single or multiple ascending dose by intravitreal injection

Part A: RO6867461Part B: RO6867461

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Colorado Springs, Colorado, 80909, United States

Location

Unknown Facility

Baltimore, Maryland, 21287, United States

Location

Unknown Facility

Dallas, Texas, 75231, United States

Location

Unknown Facility

Houston, Texas, 77030, United States

Location

Unknown Facility

Charlottesville, Virginia, 22908, United States

Location

Unknown Facility

Belfast, BT12 6BA, United Kingdom

Location

Unknown Facility

Bristol, BS1 2LX, United Kingdom

Location

Unknown Facility

London, EC1V 2PD, United Kingdom

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2013

First Posted

September 13, 2013

Study Start

December 1, 2013

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

GB(3)US(5)