Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
Trial record 2 of 530 for:    AVENUE

AVENUE: A Proof-of-Concept Study of RG7716 in Participants With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02484690
First received: June 12, 2015
Last updated: September 6, 2016
Last verified: September 2016
  Purpose
This study will evaluate the safety, tolerability, pharmacokinetics, and efficacy of RG7716 in participants with subfoveal CNV secondary to AMD.

Condition Intervention Phase
Macular Degeneration, Choroidal Neovascularization
Drug: RG7716
Drug: Ranibizumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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 RG7716 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:
  • Change from Baseline in BCVA letter score [ Time Frame: Up to approximately 36 weeks ]

Secondary Outcome Measures:
  • Percentage of participants gaining at least 15 letters from Baseline in BCVA letter score [ Time Frame: Up to approximately 36 weeks ]
  • Percentage of participants with BCVA letter score 20/40 or better [ Time Frame: Up to approximately 36 weeks ]
  • Percentage of participants with BCVA letter score 20/200 or worse [ Time Frame: Up to approximately 36 weeks ]
  • Change from Baseline in foveal center point thickness [ Time Frame: Up to approximately 36 weeks ]
  • Change from Baseline in central subfield thickness [ Time Frame: Up to approximately 36 weeks ]
  • Percentage of participants with no intraretinal fluid, subretinal fluid, cysts, or pigment epithelial detachment [ Time Frame: Up to approximately 36 weeks ]
  • Change from Baseline in total area of CNV [ Time Frame: Up to approximately 36 weeks ]
  • Change from Baseline in total area of CNV component [ Time Frame: Up to approximately 36 weeks ]
  • Change from Baseline in total area of leakage [ Time Frame: Up to approximately 36 weeks ]
  • Incidence of adverse events [ Time Frame: Up to approximately 40 weeks ]
  • Clearance of RG7716 [ Time Frame: Up to approximately 36 weeks ]
  • Volume of distribution of RG7716 [ Time Frame: Up to approximately 36 weeks ]

Estimated Enrollment: 271
Study Start Date: August 2015
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm A: Ranibizumab, 0.5 mg every 4 weeks
Participants with CNV secondary to AMD will be assigned to Arm A to receive 32 weeks of treatment with ranibizumab, 0.5 mg administered IVT every 4 weeks.
Drug: Ranibizumab
Participants will receive ranibizumab, 0.5 mg administered IVT every 4 weeks.
Experimental: Arm B: RG7716, 1.5 mg every 4 weeks
Participants with CNV secondary to AMD will be assigned to Arm B to receive 32 weeks of treatment with RG7716, 1.5 mg administered IVT every 4 weeks.
Drug: RG7716
Participants will receive RG7716, 1.5 or 6 mg, administered IVT and according to treatment assignment.
Experimental: Arm C: RG7716, 6 mg every 4 weeks
Participants with CNV secondary to AMD will be assigned to Arm C to receive 32 weeks of treatment with RG7716, 6 mg administered IVT every 4 weeks.
Drug: RG7716
Participants will receive RG7716, 1.5 or 6 mg, administered IVT and according to treatment assignment.
Experimental: Arm D: RG7716, 6 mg every 4 to 8 weeks
Participants with CNV secondary to AMD will be assigned to Arm D to receive RG7716, 6 mg administered IVT every 4 weeks up to Week 12, followed by 6 mg administered IVT every 8 weeks up to Week 28.
Drug: RG7716
Participants will receive RG7716, 1.5 or 6 mg, administered IVT and according to treatment assignment.
Experimental: Arm E: Ranibizumab + RG7716, 6 mg every 4 weeks
Participants with CNV secondary to AMD will be assigned to Arm E to receive ranibizumab, 0.5 mg administered IVT every 4 weeks up to Week 8, followed by RG7716, 6 mg administered IVT every 4 weeks up to Week 32.
Drug: RG7716
Participants will receive RG7716, 1.5 or 6 mg, administered IVT and according to treatment assignment.
Drug: Ranibizumab
Participants will receive ranibizumab, 0.5 mg administered IVT every 4 weeks.

  Eligibility

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

Inclusion Criteria:

  • Adults at least 50 years of age
  • Subfoveal CNV lesions of all types, secondary to AMD
  • 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
  • Hemoglobin A1c above 7.5 percent (%)
  • Uncontrolled blood pressure
  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: NCT02484690

Contacts
Contact: Reference Study ID Number: BP29647 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

  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
Study First Received: June 12, 2015
Last Updated: September 6, 2016

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

ClinicalTrials.gov processed this record on May 25, 2017