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Trial record 1 of 1 for:    BP29647
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A Proof-of-Concept Study of RO6867461 in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD) (AVENUE)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02484690
First Posted: June 30, 2015
Last Update Posted: November 16, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
This multiple-center, multiple-dose and regimen, randomized, double-masked active comparator-controlled, double-masked, five parallel group, 36-week study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of RO6867461 in participants with CNV secondary to AMD.

Condition Intervention Phase
Choroidal Neovascularization Drug: RO6867461 Drug: Ranibizumab Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple-Center, Multiple-Dose and Regimen, Randomized, Active Comparator Controlled, Double-Masked, Parallel Group, 36 Week Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO6867461 Administered Intravitreally in Patients With Choroidal Neovascularization Secondary to Age-Related Macular Degeneration

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean Change From Baseline in BCVA Letter Score [ Time Frame: Baseline, Week 36 ]

Secondary Outcome Measures:
  • Percentage of Participants Gaining Greater than or Equal to (>/=) 15 Letters From Baseline in BCVA Letter Score at Week 36 [ Time Frame: Baseline, Week 36 ]
  • Percentage of Participants With BCVA Score >/=20/40 Letters [ Time Frame: Week 36 ]
  • Percentage of Participants With BCVA Score </=20/200 Letters [ Time Frame: Week 36 ]
  • Mean Change From Baseline in Foveal Center Point Thickness, as Measured by Spectral Domain Optical Coherence Tomography (SD-OCT) [ Time Frame: Baseline, Week 36 ]
  • Mean Change From Baseline in Central Subfield Thickness, as Measured by SD-OCT [ Time Frame: Baseline, Week 36 ]
  • Percentage of Participants With no Intraretinal Fluid, Subretinal Fluid, Cysts, or Pigment Epithelial Detachment, as Measured by SD-OCT [ Time Frame: Week 36 ]
  • Mean Change From Baseline in Total Area of CNV, as Measured by Fundus Fluorescein Angiography (FFA) [ Time Frame: Baseline, Week 36 ]
  • Mean Change From Baseline in Total Area of CNV Component, as Measured by FFA [ Time Frame: Baseline, Week 36 ]
  • Change From Baseline in Total Area of Leakage, as Measured by FFA [ Time Frame: Baseline, Week 36 ]
  • Percentage of Participants With Adverse Events [ Time Frame: Baseline up to 36 weeks ]
  • Clearance of RO6867461 [ Time Frame: Up to 36 weeks ]
  • Volume of Distribution of RO6867461 [ Time Frame: Up to 36 weeks ]
  • Percentage of Participants With Anti-Therapeutic Antibodies to RO6867461 [ Time Frame: Baseline, Predose (0 hour) on Days 1, 28, 84, 112, 168, 252 or early termination (up to 252 days overall) ]

Enrollment: 273
Actual Study Start Date: August 11, 2015
Estimated Study Completion Date: January 31, 2018
Primary Completion Date: September 26, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Ranibizumab, 0.5 mg Every 4 Weeks (Q4W)
Participants will receive ranibizumab, 0.5 milligrams (mg) intravitreal (IVT) Q4W up to Week 32 (total 9 injections).
Drug: Ranibizumab
Ranibizumab will be administered as per the regimen specified in individual arm.
Experimental: RO6867461, 1.5 mg Q4W
Participants will receive RO6867461 1.5 mg IVT Q4W up to Week 32 (total 9 injections).
Drug: RO6867461
RO6867461 will be administered as per the regimen specified in individual arm.
Experimental: RO6867461, 6 mg Q4W
Participants will receive RO6867461 6 mg IVT Q4W up to Week 32 (9 injections).
Drug: RO6867461
RO6867461 will be administered as per the regimen specified in individual arm.
Experimental: RO6867461, 6 mg Every 4-8 weeks
Participants will receive RO6867461, 6 mg IVT (4 injections) Q4W up to Week 12, followed by 6 mg IVT (2 injections) every 8 weeks up to Week 28.
Drug: RO6867461
RO6867461 will be administered as per the regimen specified in individual arm.
Experimental: Ranibizumab 0.5 mg + RO6867461 6 mg Q4W
Participants will receive ranibizumab, 0.5 mg IVT (3 injections) Q4W up to Week 8, followed by RO6867461, 6 mg IVT (6 injections) Q4W up to Week 32.
Drug: RO6867461
RO6867461 will be administered as per the regimen specified in individual arm.
Drug: Ranibizumab
Ranibizumab will be administered as per the regimen specified in individual arm.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treatment-naive with CNV secondary to AMD, with subfoveal CNV or juxtafoveal CNV with a subfoveal component related to the CNV activity by FFA or SD-OCT
  • Active CNV

Exclusion Criteria:

  • CNV due to causes other than AMD
  • Subretinal hemorrhage, fibrosis, or atrophy involving either the fovea or more than 50% of the total lesion area
  • Cataract surgery within 3 months of baseline, or any other previous intraocular surgery
  • Major illness or surgery within 1 month prior to Screening
  • Glycosylated hemoglobin (HbA1c) above 7.5%
  • Uncontrolled blood pressure
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02484690


  Show 59 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02484690     History of Changes
Other Study ID Numbers: BP29647
First Submitted: June 12, 2015
First Posted: June 30, 2015
Last Update Posted: November 16, 2017
Last Verified: November 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents