Phase I Dose Escalation and Expansion Study of DS-7080a in Subjects With Neovascular Age-related Macular Degeneration or Diabetic Macular Edema

Status: Completed
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The purpose of this study is to test DS-7080a, a monoclonal antibody, as a new treatment for neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME). The hypothesis of the study is that DS-7080a is safe and shows preliminary efficacy in patients with these conditions either alone or in combination with ranibizumab. This study is organized into 3 Parts: Part 1 Dose Escalation in AMD participants, Part 2 Dose Expansion in AMD participants, and Part 3 Dose Expansion in DME participants. In Part 1, participants will be enrolled into 3 sequential, ascending dose-level cohorts in non-randomized uncontrolled manner with the main purpose to determine the recommended dose. In Part 2, participants will be randomized to 1 of 3 arms of either monotherapy with DS-7080a or monotherapy with ranibizumab, which is an active control, or combination therapy of DS-7080a plus ranibizumab (ranibizumab will be administered 30 minutes prior to DS-7080a). In Part 3, subjects with DME will be assigned to 1 of 2 arms of either monotherapy with DS-7080a or monotherapy with ranibizumab. DS-7080a or ranibizumab will be administered 3 times: on Baseline/Day 1, Day 29, and Day 57. Both Parts 2 and 3 will consist of 8 visits including a 14-day screening phase, an 84-day treatment period, and a 28-day follow-up period.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ For parts 1 and 2:

• ≥ 50 years of age

• Has active primary subfoveal choroid neovascularization (CNV) lesions secondary to age-related macular degeneration (AMD)

• CNV ≥ 50% of total lesion size in study eye

• Central sub-field thickness \> 315 µm on spectral domain optical coherence tomography (SD-OCT) in the study eye

• Has BCVA letter score required at screening visit:

• For Part 1, ≤ 49 (approximately 20/100 or worse) in the study eye and ≥ 49 (approximately 20/100 or better) in the fellow eye

• For Part 2, 78 to 25 (approximately 20/32 to 20/320) in the study eye

⁃ For Part 3:

• Is ≥ 18 years of age with retinal thickening due to diabetic macular edema (DME)

• Has central sub-field thickness (CST) \> 335 μm in the study eye

• Has BCVA letter score at screening visit 78 to 25 letters (approximately 20/32 to 20/320) in the study eye

Locations
United States
Arizona
Phoenix
California
Arcadia
Beverly Hills
Palm Desert
Florida
Fort Myers
Massachusetts
Boston
Maryland
Baltimore
Nebraska
Omaha
Texas
Abilene
Austin
San Antonio
Washington
Silverdale
Time Frame
Start Date: 2015-07
Completion Date: 2018-01-02
Participants
Target number of participants: 56
Treatments
Experimental: Part 1 DS-7080a dose escalation
3 sequential ascending dose levels (1.0, 2.0, 4.0 mg), every 4 weeks for 12 weeks
Experimental: Part 2 DS-7080a
Specific dose (either the maximum tolerated dose or 4.0 mg) of DS-7080a determined in Part 1, every 4 weeks for 12 weeks
Active_comparator: Part 2 ranibizumab
Ranibizumab 0.5 mg, every 4 weeks for 12 weeks
Experimental: Part 2 DS-7080a and ranibizumab
Specific dose of DS-7080a determined in Part 1 and ranibizumab 0.5 mg, every 4 weeks for 12 weeks
Experimental: Part 3 DS-7080a
Specific dose of DS-7080a determined in Part 1, every 4 weeks for 12 weeks
Experimental: Part 3 ranibizumab
Ranibizumab 0.3 mg, every 4 weeks for 12 weeks
Sponsors
Leads: Daiichi Sankyo

This content was sourced from clinicaltrials.gov

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