MMP-9 Inhibition for Recalcitrant Wet AMD

ConditionsExudative Macular Degeneration Wet Age-related Macular Degeneration

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Doxycycline Hyclate
Drug
Doxycycline Hyclate capsules, USP 50 mg
Placebo
Drug
Placebo

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: DoxycyclineExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Resolution of the persistent retinal fluid on optical coherence tomography (OCT)

percentage of patients with retinal fluid-free status

Time frame

9 months

Secondary outcomes

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

Other outcomes

Ocular Adverse Events

intra-ocular pressure elevation ( more than 10 mmHg) requiring topical ocular hypertensive medications, endophthalmitis, retinal tear and detachment, uveitis, and thromboembolic events will be recorded

Time frame

Baseline to 9 months

Systemic Adverse Events

Allergy or hypersensitivity drug reactions

Time frame

Baseline to 9 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Iowa

Lead sponsor

Source ClinicalTrials.gov

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