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Age-Related Macular Degeneration (ARMD) Clinical Trials

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MMP-9 Inhibition for Recalcitrant Wet Age-Related Macular Degeneration (AMD)

Who is this study for? Patients with recalcitrant wet age-related macular degeneration
What treatments are being studied? Doxycycline Hyclate
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 99
Healthy Volunteers: f
View:

• Wet age-related macular degeneration (wAMD);

• Solely treated with anti-VEGF IVI for active CNV due to wAMD. However, enrolled patients can have other retinal pathologies such as diabetic retinopathy or vein occlusion for which they are not being treated with anti-VEGF IVI;

• Must have persistent sub-retinal with or without intra-retinal fluid due to active CNV from wAMD despite receiving at least three consecutive injections with any anti-VEGF agent;

• Must not have encountered previous side effects from tetracycline medications.

Locations
United States
Iowa
University of Iowa Hospitals & Clinics Department of Ophthalmology & Visual Sciences
RECRUITING
Iowa City
Contact Information
Primary
Elliott H Sohn, MD
elliott-sohn@uiowa.edu
3193563285
Time Frame
Start Date: 2020-11-04
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 50
Treatments
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
Authors
Razek G Coussa
Related Therapeutic Areas
Late-Onset Retinal Degeneration
Age-Related Macular Degeneration (ARMD)
Sponsors
Leads: University of Iowa

This content was sourced from clinicaltrials.gov

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