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New treatment option for Exudative Macular Degeneration
Official title MMP-9 Inhibition for Recalcitrant Wet AMD
ClinicalTrials.gov ID: NCT04504123
What this study is testing
What is Doxycycline Hyclate?
Doxycycline Hyclate is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for exudative macular degeneration.
Also referred to as Antibiotic - tetracycline compound.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 9 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 99
You may be able to join if
- 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...
- Must have persistent sub-retinal with or without intra-retinal fluid due to active CNV from wAMD despite receiving at least three consecutive...
- Must not have encountered previous side effects from tetracycline medications.
You likely can't join if
- Ocular:
- 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...
- History of peribulbar corticosteroid injection to the studied eye or the fellow eye within the past 6 months;
See the full eligibility 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...
- 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.
- Ocular:
- 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;
- History of peribulbar corticosteroid injection to the studied eye or the fellow eye within the past 6 months;
- History of intravitreal triamcinolone acetonide injection to the studied eye within the past 4 months;
- An ocular condition (other than AMD) is present in the studied eye that, in the opinion of the investigator, might alter visual acuity during the course of the study (e.g., retinal vein occlusion, uveitis or other...
- CNV due to causes other than wAMD;
- Inability to follow up at the 6th and 9th months time points after recruitment;
- Missing two or more consecutive injections during the six months treatment period;
- Patient requiring imminent need for IVI anti-VEGF medication switch or another treatment intervention, such as photodynamic therapy, during the 9 months trial period;
- Presence of fluid associated with geographic atrophy or disciform scar;
- Any patient with sub-retinal and/or intra-retinal fluid that is not due to CNV (eg, overlying areas of geographic atrophy;
- Any patient actively being actively treated for Irvine-Gass Syndrome. Exclusion Criteria - Systemic:
- Patient with and/or who developed an unstable medical status (e.g., glycemic control, blood pressure, cardiovascular disease, individuals who are unlikely or unable to complete the 9 months trial period) in the opinion...
- Significant renal disease (defined as a serum creatinine \>2.5 mg/dL);
- Systolic blood pressure \>180 mm Hg or diastolic blood pressure \>110 mm Hg;
- History of headaches associated with tetracycline therapy
- History of pseudotumor cerebri;
- History of tetracycline therapy within the past 6 months;
- Pregnancy or patient intending to become pregnant within the 9 months of the trial period. For women of child-bearing potential, a pregnancy test will be performed;
- Sexually active women of child-bearing potential not actively practicing birth control by using a medically accepted device or therapy (i.e., intrauterine device, hormonal contraceptive, or barrier device) during the...
- Known allergy/intolerance to doxycycline, tetracyclines, or any ingredient in the study drug or placebo;
- Patients receiving phenytoin, barbiturates, carbamazepine, digoxin, or isotretinoin; patients with gastroparesis; patients with a history of gastrectomy, gastric bypass surgery, or otherwise deemed achlorhydric should...
- Patients taking strontium, acitretin, or tretinoin should excluded due to the potential for serious interactions with doxycycline;
- Patients with abnormal ALT or AST at baseline will be referred to their primary care physician for medical clearance for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Iowa City, Iowa, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 9 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 50 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Iowa City, Iowa, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.