MMP-9 Inhibition for Recalcitrant Wet AMD

Part of paid clinical trials in Iowa City, Iowa.

Sponsor
University of Iowa
Study ID
NCT04504123
Phase
PHASE2
Status
Recruiting
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Conditions

  • Exudative Macular Degeneration
  • Wet Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Doxycycline Hyclate — DRUG
    Doxycycline Hyclate capsules, USP 50 mg
  • Placebo — DRUG
    Placebo

Study Details

Wet (or neovascular) form of age-related macular degeneration (wAMD) is the most common cause of blindness in the Western world. Currently, anti-vascular endothelial growth factor (VEGF) intravitreal injections (IVI) remain the standard-of-care treatment for wAMD. Previous studies show that about 90% of treated patients lose minimal visual function after 2 years of follow-up. There is still, a subset of 15% patients, incomplete responders, that do not improve and possibly worsen due to the persistence of sub-retinal fluid (with or without intra-retinal fluid) with chronic treatment. The investigators plan to evaluate the effect of oral doxycycline versus placebo on the anatomic and functional outcomes in persistent sub-retinal eye fluid in neovascular wet age-related macular degeneration. This subset are incomplete or non-responders to current anti-VEGF intravitreal therapy.

Key Dates

Start date
Nov 4, 2020
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Mar 1, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Doxycycline
    Participants received doxycycline hyclate 50 mg capsule orally once a day for 6 months
  • Placebo Comparator: Placebo
    Participants received placebo (inactive) capsule orally once a day for 6 months

Primary Outcome Measure

Resolution of the persistent retinal fluid on optical coherence tomography (OCT) [ Time Frame: 9 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Iowa Hospitals & Clinics Department of Ophthalmology & Visual SciencesIowa CityIowa52242
Christine A Sinkey, BSN, CCRC
[email protected]
3193538723
Elliott H Sohn, MD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Iowa Hospitals & Clinics Department of Ophthalmology & Visual Sciences· Iowa City, IA

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