Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04504123
Status:
RECRUITING
Last Update Posted:
2023-03-07
First Post:
2020-08-04
Brief Title:
MMP-9 Inhibition for Recalcitrant Wet AMD
Sponsor:
University of Iowa
Organization:
University of Iowa
Study Overview
Official Title:
MMP-9 Inhibition for Recalcitrant Wet Age-Related Macular Degeneration AMD
Status:
RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed 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 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None