MMP-9 Inhibition for Recalcitrant Wet Age-Related Macular Degeneration (AMD)
University of Iowa
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.
Description
The investigators plan to conduct a double masked, randomized study to assess the effect of low dose, oral doxycycline 50 mg once a day versus placebo in patients with wet age-related macular degeneration who are incomplete responders to anti-VEGF extended treatment regimens. The study will be conducted over 9 months with every 3 month assessments; 6 months administration period of doxycycline versus placebo (double masked, randomized) and a 3 month follow up period. The participant visits will occur during clinic visits for standard-of-care intravitreal injections (IVI). Medical information…
Eligibility
- Age range
- 50–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria - Ocular: * History…
Interventions
- DrugDoxycycline Hyclate
Doxycycline Hyclate capsules, USP 50 mg
- DrugPlacebo
Placebo
Location
- University of Iowa Hospitals & Clinics Department of Ophthalmology & Visual SciencesIowa City, Iowa