Study of DS-7080a for the Treatment of Macular Degeneration

Completed · Phase 1

Conditions studied: Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema

In brief

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.

Key facts

Study ID

NCT02530918

Run by

Daiichi Sankyo

People needed

56

Starts

2015-07-01

Expected to finish

2018-01-02

Last updated by the study team

2018-05-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• For Parts 1 and 2:
• Has used any long acting steroids, either systemically or intraocularly, within 6 months of Baseline Visit
• Has total lesion size > 12 disc areas (30.5 mm2) in the study eye
• Has presence of retinal pigment epithelial tears or rips involving the macula in the study eye
• Has history of any vitreous hemorrhage within 4 weeks prior to Screening Visit in the study eye
• Has presence of causes of CNV other than AMD
• Had prior vitrectomy in the study eye
• Has history of retinal detachment or treatment or surgery for retinal detachment in the study eye
• Has any history of a full thickness macular hole in the study eye
• Had any intraocular or periocular surgery within 3 months of Baseline Visit on the study eye, except lid surgery
• Has uncontrolled glaucoma in the study eye
• Has active intraocular inflammation or periocular infection in either eye
• Has any history of uveitis in either eye of scleromalacia in either eye
• Has aphakia or pseudophakia in the study eye
• Had previous therapeutic radiation in the region of the study eye
• Has history of corneal transplant or corneal dystrophy in the study eye
• Has significant media opacities in the study eye (e.g. cataract) that could require either medical or surgical intervention during the study period
• Is a women who is pregnant, breastfeeding, or of childbearing potential and unwilling to practice two measures of adequate contraception throughout the study
• For Part 1 only:
• Had any ocular (in the study eye) or systemic treatment or surgery for neovascular AMD within 4 weeks of Baseline Visit, except dietary supplements or vitamins
• Has a subretinal hemorrhage that is ≥ 50% of the total lesion area in the study eye
• Has scarring or fibrosis, making up >50% of total lesion or involving the center of the fovea in the study eye
• For Part 2 only:
• Had any prior therapy in the study eye within 3 months of Baseline Visit, except dietary supplements or vitamins
• For Part 3:

Where it is running

• Study site — Phoenix, Arizona, United States
• Study site — Arcadia, California, United States
• Study site — Beverly Hills, California, United States
• Study site — Palm Desert, California, United States
• Study site — Fort Myers, Florida, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Omaha, Nebraska, United States
• Study site — Abilene, Texas, United States
• Study site — Austin, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Silverdale, Washington, United States

Full record on ClinicalTrials.gov

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