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.
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 will be acquired from the standard of care optical coherence tomography (OCT), visual acuity (VA), and IVI administered (number, frequency and type of drug). Blood plasma and aqueous fluid (anterior chamber tap) samples and study drug tolerability will be obtained at baseline, 6 months and 9 months. Plasma will be obtained to assay for inflammatory markers: MMP-9 levels and questionnaires will be obtained on 1) vision quality of life, and 2) study drug tolerance at Baseline, 6 months and 9 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Doxycycline Hyclate capsules, USP 50 mg
Placebo
University of Iowa Hospitals & Clinics Department of Ophthalmology & Visual Sciences
Iowa City, Iowa, United States
RECRUITINGResolution of the persistent retinal fluid on optical coherence tomography (OCT)
percentage of patients with retinal fluid-free status
Time frame: 9 months
Change in optical coherence tomography (OCT) central media thickness (CMT)
mean change in central media thickness
Time frame: 9 months compared to baseline
Change in best corrected visual acuity (BCVA)
mean change in logMAR / percentage of patients with a gain or loss of more than 5 ETDRS letters
Time frame: 6 months and 9 months compared to Baseline
Number of intravitreal injections (IVI) administered
total number of anti-VEGF intravitreal injections
Time frame: 6 months and 9 months
Inflammatory mediators matrix metalloproteinases MMP-9 and MMP-9 activity
anterior eye aqueous fluid and blood plasma
Time frame: Baseline, 6 months and 9 months
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