MMP-9 Inhibition for Recalcitrant Wet AMD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-99
SponsorUniversity of Iowa
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
History of uveitis (including endophthalmitis) or presence of intraocular inflammation;
Presence of significant epiretinal membrane or macular hole causing distortion of macular anatomy;
Presence of media opacity preventing discerning of fluid on OCT;
Any prior ophthalmic surgery (including YAG or retinal laser) within the previous 3 months or anticipated need for any ophthalmic surgery (including cataract extraction) for 9 months following randomization;
Trial design
Treatments tested in this trial
- Doxycycline Hyclate
- Placebo
Treatment groups
50 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov