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A Phase 2 Study of RO6867461 in Participants With Center-Involving Diabetic Macular Edema (CI-DME) (BOULEVARD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02699450
First received: March 1, 2016
Last updated: May 4, 2016
Last verified: April 2016
  Purpose
This is a multiple-center, multiple-dose, randomized, active comparator-controlled, double-masked, three parallel group, 28-week study in participants with CI-DME. Only one eye will be selected as the study eye. Where both eyes meet all eligibility criteria, the eye with the worse best corrected visual acuity (BCVA) will be defined as the study eye. Participants will be randomized into each arm group (1:1:1) and total duration of the study will be approximately 32 weeks.

Condition Intervention Phase
Diabetic Macular Edema
Drug: RO6867461
Drug: Ranibizumab
Drug: Sham
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Mean change from baseline in BCVA at week 24 using early treatment diabetic retinopathy study (ETDRS) modified charts [ Time Frame: Baseline, Week 24 ]
  • Apparent plasma clearance of RO6867461 [ Time Frame: Pre-dose on Days 1, 28, 84, 140, and 168; post-dose on Days 7, 182, and 196 or early termination ]
  • Apparent plasma volume of RO6867461 [ Time Frame: Pre-dose on Days 1, 28, 84, 140, and 168; post-dose on Days 7, 182, and 196 or early termination ]

Secondary Outcome Measures:
  • Percentage of participants gaining greater than or equals (>/=) 15 letters from baseline BCVA at Week 24 [ Time Frame: Baseline, and Week 24 ]
  • Percentage of participants with BCVA >/=69 letters (20/40 or better) at Week 24 [ Time Frame: Week 24 ]
  • Percentage of participants with BCVA >/=84 letters (20/20 or better) at Week 24 [ Time Frame: Week 24 ]
  • Mean change from baseline in BCVA at Week 28 [ Time Frame: Baseline, and Week 28 ]
  • Mean change from baseline in foveal center point thickness at Week 24 and 28, as measures by spectral domain optical coherence tomography (SD-OCT) [ Time Frame: Baseline, Weeks 24, and 28 ]
  • Mean change from baseline in mean central subfield thickness (CST) at Week 24 and 28, as measures by SD-OCT [ Time Frame: Baseline, Weeks 24, and 28 ]
  • Percentage of participants with resolution of subretinal and intraretinal fluid at Week 24 and 28, as measures by SD-OCT [ Time Frame: Weeks 24, and 28 ]
  • Percentage of participants with resolution of leakage at the macula at Week 24, as measures by fundus fluorescein angiography (FFA) [ Time Frame: Week 24 ]
  • Change from baseline in the size of the foveal avascular zone at Week 24, as measures by FFA [ Time Frame: Baseline and Week 24 ]
  • Change from baseline in plasma levels of vascular endothelial growth factor (VEGF) [ Time Frame: Baseline, Weeks 1, 4, 12, 24, 26, and 28 or early termination ]
  • Change from baseline in plasma levels of angiopoietin-2 (Ang-2) [ Time Frame: Baseline, Weeks 1, 4, 12, 24, 26, and 28 or early termination ]
  • Maximum observed plasma concentration (Cmax) of RO6867461 [ Time Frame: Pre-dose on Days 1, 28, 84, 140, and 168; post-dose on Days 7, 182, and 196 or early termination ]
  • Area under the plasma concentration-time curve from time zero to extrapolated infinite time [AUC (0-inf)] of RO6867461 [ Time Frame: Pre-dose on Days 1, 28, 84, 140, and 168; post-dose on Days 7, 182, and 196 or early termination ]
  • Area under the plasma concentration-time curve from time zero to end of dosing interval [AUC (0-tau)] of RO6867461 [ Time Frame: Pre-dose on Days 1, 28, 84, 140, and 168; post-dose on Days 7, 182, and 196 or early termination ]
  • Time to reach maximum observed plasma concentration (Tmax) of RO6867461 [ Time Frame: Pre-dose on Days 1, 28, 84, 140, and 168; post-dose on Days 7, 182, and 196 or early termination ]
  • Plasma decay half-life (t1/2) of RO6867461 [ Time Frame: Pre-dose on Days 1, 28, 84, 140, and 168; post-dose on Days 7, 182, and 196 or early termination ]
  • Number of participants with adverse events [ Time Frame: Baseline up to Week 28 or early termination ]
  • Number of participants with anti-RO6867461 antibodies [ Time Frame: Baseline, Weeks 1, 4, 12, 20, 24, 26, and 28 or early termination ]

Estimated Enrollment: 150
Study Start Date: March 2016
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RO6867461 1.5 mg
Participants will receive 1.5 milligrams (mg) RO6867461 inravitreal (IVT) every 4 weeks up to Week 20, followed by 1 sham administration at Week 24.
Drug: RO6867461
Participants will receive 6 injections of 1.5 mg or 6 mg RO6867461 IVT every 4 weeks up to Week 20.
Drug: Sham
Participants will receive 1 sham administration, mimicking the action of an injection, at Week 24.
Experimental: RO6867461 6 mg
Participants will receive 6 mg RO6867461 IVT every 4 weeks up to Week 20, followed by 1 sham administration at Week 24.
Drug: RO6867461
Participants will receive 6 injections of 1.5 mg or 6 mg RO6867461 IVT every 4 weeks up to Week 20.
Drug: Sham
Participants will receive 1 sham administration, mimicking the action of an injection, at Week 24.
Active Comparator: Ranibizumab 0.3 mg
Participants will receive 0.3 mg ranibizumab IVT every 4 weeks up to Week 24.
Drug: Ranibizumab
Participants will receive 7 injections of 0.3 mg ranibizumab IVT every 4 weeks upto Week 24.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Macular edema associated with diabetic retinopathy (DR)
  • Decreased visual activity (VA) attributable primarily to DME
  • Diagnosis of diabetes mellitus (DM)

Exclusion Criteria:

  • Proliferative diabetic retinopathy (PDR)
  • Cataract surgery within 3 months of Baseline, or any other previous intraocular surgery
  • Uncontrolled glaucoma
  • Current or history of ocular disease in the study eye other than DME
  • Major illness or major surgical procedure within 1 month prior to Day 1
  • Uncontrolled blood pressure
  • Glycosylated hemoglobin (HbA1c) greater than (>) 10 percent (%) at screening
  • Untreated diabetes mellitus or initiation of oral anti-diabetic medication or insulin within 4 months prior to Day 1
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02699450

Contacts
Contact: Reference Study ID Number: BP30099 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

  Show 53 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: NCT02699450     History of Changes
Other Study ID Numbers: BP30099  RG7716 
Study First Received: March 1, 2016
Last Updated: May 4, 2016

Additional relevant MeSH terms:
Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Signs and Symptoms
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 24, 2017