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

November 1, 2016 updated by: Hoffmann-La Roche

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Belfast, United Kingdom, BT12 6BA
      • Bristol, United Kingdom, BS1 2LX
      • London, United Kingdom, EC1V 2PD
  • United States
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
    • Maryland
      • Baltimore, Maryland, United States, 21287
    • Texas
      • Dallas, Texas, United States, 75231
      • Houston, Texas, United States, 77030
    • Virginia
      • Charlottesville, Virginia, United States, 22908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Part A, 12 weeks; Part B, 20 weeks
Safety: Incidence of adverse events
Time Frame: Part A, 12 weeks; Part B, 20 weeks
Part A, 12 weeks; Part B, 20 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Pharmacokinetics: Area under the concentration time curve (AUC)
Time Frame: Part A, 12 weeks; Part B, 20 weeks
Part A, 12 weeks; Part B, 20 weeks
Pharmacokinetics: Maximum plasma concentration (Cmax)
Time Frame: Part A, 12 weeks; Part B, 20 weeks
Part A, 12 weeks; Part B, 20 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

September 3, 2013

First Submitted That Met QC Criteria

September 12, 2013

First Posted (Estimate)

September 13, 2013

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP28936
  • 2013-001972-40 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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