RECRUITING

MMP-9 Inhibition for Recalcitrant Wet AMD

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Conditions

Exudative Macular DegenerationWet Age-related Macular DegenerationActive choroidal neovascularization (CNV)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

MMP-9 Inhibition for Recalcitrant Wet Age-Related Macular Degeneration (AMD)

Quick Facts

Study Start:2020-11-04
Study Completion:2024-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04504123

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Wet age-related macular degeneration (wAMD);
  2. * 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;
  3. * 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;
  4. * Must not have encountered previous side effects from tetracycline medications.
  5. * History of uveitis (including endophthalmitis) or presence of intraocular inflammation;
  6. * Presence of significant epiretinal membrane or macular hole causing distortion of macular anatomy;
  7. * Presence of media opacity preventing discerning of fluid on OCT;
  8. * 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;
  9. * History of peribulbar corticosteroid injection to the studied eye or the fellow eye within the past 6 months;
  10. * History of intravitreal triamcinolone acetonide injection to the studied eye within the past 4 months;
  11. * 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 ocular inflammatory disease, neovascular glaucoma, and Irvine-Gass syndrome);
  12. * CNV due to causes other than wAMD;
  13. * Inability to follow up at the 6th and 9th months time points after recruitment;
  14. * Missing two or more consecutive injections during the six months treatment period;
  15. * Patient requiring imminent need for IVI anti-VEGF medication switch or another treatment intervention, such as photodynamic therapy, during the 9 months trial period;
  16. * Presence of fluid associated with geographic atrophy or disciform scar;
  17. * Any patient with sub-retinal and/or intra-retinal fluid that is not due to CNV (eg, overlying areas of geographic atrophy;
  18. * Any patient actively being actively treated for Irvine-Gass Syndrome.
  19. * 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 of the investigator;
  20. * Significant renal disease (defined as a serum creatinine \>2.5 mg/dL);
  21. * Systolic blood pressure \>180 mm Hg or diastolic blood pressure \>110 mm Hg;
  22. * History of headaches associated with tetracycline therapy
  23. * History of pseudotumor cerebri;
  24. * History of tetracycline therapy within the past 6 months;
  25. * 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;
  26. * 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 study period (at least 24 months). This is important as doxycycline may interfere with the effectiveness of hormonal contraceptives. Hence, sexually active women of child-bearing potential who use a hormonal contraceptive will be required to use a second form of contraception to safeguard against contraceptive failure while participating in the study;
  27. * Known allergy/intolerance to doxycycline, tetracyclines, or any ingredient in the study drug or placebo;
  28. * 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 all be excluded due to altered doxycycline pharmacokinetics and/or bioavailability;
  29. * Patients taking strontium, acitretin, or tretinoin should excluded due to the potential for serious interactions with doxycycline;
  30. * Patients with abnormal ALT or AST at baseline will be referred to their primary care physician for medical clearance for participation in this study.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Elliott H Sohn, MD
CONTACT
3193563285
elliott-sohn@uiowa.edu

Principal Investigator

Elliott H Sohn, MD
PRINCIPAL_INVESTIGATOR
University of Iowa

Study Locations (Sites)

University of Iowa Hospitals & Clinics Department of Ophthalmology & Visual Sciences
Iowa City, Iowa, 52242
United States

Collaborators and Investigators

Sponsor: University of Iowa

  • Elliott H Sohn, MD, PRINCIPAL_INVESTIGATOR, University of Iowa

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-11-04
Study Completion Date2024-03-01

Study Record Updates

Study Start Date2020-11-04
Study Completion Date2024-03-01

Terms related to this study

Keywords Provided by Researchers

  • Active choroidal neovascularization (CNV)

Additional Relevant MeSH Terms

  • Exudative Macular Degeneration
  • Wet Age-related Macular Degeneration