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Trial record 1 of 142 for:    boulevard
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A Study of RO6867461 in Participants With Center-involving Diabetic Macular Edema (BOULEVARD)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02699450
First received: March 1, 2016
Last updated: June 29, 2017
Last verified: June 2017
  Purpose
This is a multiple-center, multiple-dose, randomized, active comparator-controlled, double-masked, three parallel group, 36-week study in participants with center-involving diabetic macular edema (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. The study will consist of a treatment period (20 weeks) and an observational period (up to 16 weeks). Treatment naive participants will be randomized in a 1:1:1 ratio to one of the Arms A, B and C, respectively. Participants previously treated with intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) will be randomized in a 1:1 ratio to Arms A and C.

Condition Intervention Phase
Diabetic Macular Edema 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, 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 Diabetic Macular Edema

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 at Week 24, in Treatment-Naive Participants [ Time Frame: Baseline, Week 24 ]
    BVCA letter score will be assessed using modified Early Treatment Diabetic Retinopathy Study (ETDRS) charts.


Secondary Outcome Measures:
  • Percentage of Participants who Gain ≥ 15 Letters in BCVA Letter Score [ Time Frame: Baseline up to Week 24 ]
    BVCA letter score will be assessed using modified ETDRS charts.

  • Percentage of Participants with BCVA ≥ 69 Letters (20/40 or Better) in BCVA Letter Score [ Time Frame: Week 24 ]
    BVCA letter score will be assessed using modified ETDRS charts.

  • Percentage of Participants With BCVA ≥ 84 Letters (20/20 or Better) in BCVA Letter Score [ Time Frame: Week 24 ]
    BVCA letter score will be assessed using modified ETDRS charts.

  • Mean Change from Baseline in Foveal Center Point Thickness at Week 24 [ Time Frame: Baseline, Week 24 ]
    Foveal center point thickness will be measured using spectral domain optical coherence tomography (SD-OCT).

  • Mean Change from Baseline in Mean CST at Week 24 [ Time Frame: Baseline, Week 24 ]
    CST will be measured using SD-OCT.

  • Percentage of Participants with Resolution of Subretinal and Intraretinal Fluid [ Time Frame: Week 24 ]
    Resolution of subretinal and intraretinal fluid will be measured using SD-OCT.

  • Percentage of Participants with Resolution of Leakage at the Macula [ Time Frame: Week 24 ]
    Resolution of leakage at the macula will be measured using fundus fluorescein angiography (FFA).

  • Change from Baseline in the Size of the Foveal Avascular Zone at Week 24 [ Time Frame: Baseline, Week 24 ]
    Size of the foveal avascular zone will be measured using FFA.

  • Change from Baseline in VEGF Plasma [ Time Frame: Up to 36 Weeks ]
  • Change from Baseline in Angiopoietin-2 (Ang-2) Plasma Levels [ Time Frame: Up to 36 Weeks ]
  • Maximum Observed Plasma Concentration (Cmax) of RO6867461 [ Time Frame: Up to 36 Weeks ]
  • Area Under the Plasma Concentration-Time Curve from Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of RO6867461 [ Time Frame: Up to 36 Weeks ]
  • Area Under the Plasma Concentration-Time Curve from Time Zero to End of Dosing Interval [AUC (0-tau)] of RO6867461 [ Time Frame: Up to 36 Weeks ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of RO6867461 [ Time Frame: Up to 36 Weeks ]
  • Plasma Decay Half-Life (t1/2) of RO6867461 [ Time Frame: Up to 36 Weeks ]
  • Percentage of Participants With Adverse Events (AEs) [ Time Frame: Baseline up to Week 36 (or early termination) ]
  • Percentage of Participants With Anti-RO6867461 Antibodies [ Time Frame: Baseline up to Week 36 (or early termination) ]
  • Apparent Plasma Clearance of RO6867461 [ Time Frame: Up to 36 Weeks ]
  • Apparent Plasma Volume of RO6867461 [ Time Frame: Up to 36 Weeks ]

Enrollment: 230
Actual Study Start Date: April 27, 2016
Estimated Study Completion Date: May 4, 2018
Estimated Primary Completion Date: September 15, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A: 0.3 mg Ranibizumab
Participants will receive 0.3 milligrams (mg) ranibizumab every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant meets pre-specified criteria the participant will receive a single dose of 0.3 mg ranibizumab and exit the study.
Drug: Ranibizumab
Ranibizumab will be administered by IVT injection in the study eye.
Other Name: Lucentis
Experimental: Arm B: 1.5 mg RO6867461
Participants will receive 1.5 mg RO6867461 every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant meets pre-specified criteria the participant will receive a single dose of 0.3 mg ranibizumab and exit the study.
Drug: RO6867461
RO6867461 will be administered by IVT injection in the study eye.
Other Name: RG7716
Experimental: Arm C: 6 mg RO6867461
Participants will receive 6 mg RO6867461 every fourth week up to Week 20, for a total of 6 administrations, followed by an observational period up to Week 36. If a participant meets pre-specified criteria the participant will receive a single dose of 0.3 mg ranibizumab and exit the study.
Drug: RO6867461
RO6867461 will be administered by IVT injection in the study eye.
Other Name: RG7716

  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
  • Decreased visual acuity attributable primarily to DME
  • Diagnosis of diabetes mellitus

Exclusion Criteria:

  • High risk proliferative diabetic retinopathy
  • 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 (>) 12 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

  Show 76 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 ( Other Identifier: Roche theme number )
Study First Received: March 1, 2016
Last Updated: June 29, 2017

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

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

ClinicalTrials.gov processed this record on September 21, 2017