50 Participants NeededMy employer runs this trial

Doxycycline Hyclate for Wet AMD

EH
Overseen ByElliott H Sohn, MD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Iowa
Must be taking: Anti-VEGF
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether the antibiotic doxycycline (Doxycycline Hyclate) can benefit individuals with wet age-related macular degeneration (wAMD) who still have fluid in their eyes despite regular treatment. The standard treatment often doesn't fully work for everyone, so the study compares doxycycline to a placebo to assess improvements in eye health and vision. Individuals with wAMD who continue to experience fluid build-up after at least three anti-VEGF injections might be suitable candidates for this trial. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop all current medications, but you cannot participate if you are taking certain drugs like phenytoin, barbiturates, carbamazepine, digoxin, isotretinoin, strontium, acitretin, or tretinoin due to potential interactions with doxycycline.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that oral doxycycline is usually well-tolerated. One study found that low doses of doxycycline were safe, with only a few patients developing wet AMD, a type of age-related eye disease. Another study examined doxycycline's effects on the eyes and found it reduced the need for extra eye injections without causing serious problems. These findings suggest doxycycline is safe for patients, with only minor side effects reported.12345

Why do researchers think this study treatment might be promising for wAMD?

Most treatments for wet age-related macular degeneration (AMD) involve injections of anti-VEGF drugs directly into the eye. However, Doxycycline Hyclate is unique because it's taken orally, potentially offering a more convenient option for patients. Researchers are excited about this treatment because doxycycline has anti-inflammatory properties that could help reduce the progression of wet AMD, which is different from the usual focus on inhibiting blood vessel growth. This new approach could broaden the strategies available for managing the condition, making it a promising area of study.

What evidence suggests that doxycycline hyclate might be an effective treatment for wet AMD?

This trial will compare Doxycycline Hyclate with a placebo to evaluate its effectiveness in treating wet age-related macular degeneration (wAMD). Studies have shown that doxycycline can slow the growth of new blood vessels, which is crucial for treating wAMD because unwanted blood vessel growth can cause vision problems. Research suggests that oral doxycycline might reduce the number of eye injections needed to manage wAMD. In animal studies, doxycycline effectively slowed the progression of choroidal neovascularization, a key issue in wAMD. While more research is needed, these findings suggest doxycycline could improve outcomes for those who do not fully respond to current treatments.15678

Who Is on the Research Team?

EH

Elliott H Sohn, MD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for adults with wet age-related macular degeneration (wAMD) who still have eye fluid after at least three anti-VEGF injections. It's not for those previously treated with anything other than anti-VEGF or who've had bad reactions to tetracycline drugs.

Inclusion Criteria

I have wet age-related macular degeneration.
You cannot have had bad reactions to tetracycline medications before.
I have only received anti-VEGF injections for wet AMD, not for other eye conditions.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral doxycycline or placebo for 6 months

6 months
Clinic visits every 3 months for assessments and standard-of-care intravitreal injections

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months
Clinic visit at 9 months for final assessment

What Are the Treatments Tested in This Trial?

Interventions

  • Doxycycline Hyclate
  • Placebo

Trial Overview

The study tests if oral doxycycline can help wAMD patients who don't fully respond to standard eye injections. Participants will randomly receive either doxycycline or a placebo to see if there's an improvement in their condition.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: DoxycyclineExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials
486
Recruited
934,000+

Citations

Oral Doxycycline Reduces the Total Number of Intraocular ...

The aim of this study was to evaluate the efficacy of oral doxycycline in reducing the total number of intraocular injections needed for controlling neovascular ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/29367931/

Oral Doxycycline Reduces the Total Number of Intraocular ...

The aim of this study was to evaluate the efficacy of oral doxycycline in reducing the total number of intraocular injections needed for controlling neovascular ...

Doxy: Worth its Moxie

This data suggests that, along with antimicrobial functions, doxycycline also possesses strong anti-angiogenic properties. This could be of ...

Age-Related Macular Degeneration (AMD) Treatments

There is no cure for wet or dry AMD. However, certain treatments can slow AMD progression. Treating macular degeneration can help preserve your sight.

Study Supports Treatment Choices for Wet AMD

This research confirms for ophthalmologists that Lucentis and Avastin are similarly effective in treating wet AMD, and also provides clearer guidance on ...

Novel Targets for Geographic Atrophy

Preliminary data revealed low-dose doxycycline remained safe among the study cohort members, with a rate of wet AMD development of 2.4% and a ...

Neovascular Age-Related Macular Degeneration (nAMD)

Neovascular Age-Related Macular Degeneration (nAMD) Phase Trials for Doxycycline (DB00254) ; DBCOND0131728 (Neovascular Age-Related Macular Degeneration (nAMD)) ...

Wet AMD Therapies in the Pipeline

An ongoing two-stage phase 2 clinical trial (NCT05387837) is looking at subcutaneous D-4517.2 at dose-escalating concentrations in 30 patients with wet AMD.