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Doxycycline Hyclate for Wet AMD

Phase 2

Recruiting

Led By Elliott H Sohn, MD

Research Sponsored by University of Iowa

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Wet age-related macular degeneration (wAMD);

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;

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months and 9 months

Awards & highlights

Study Summary

This trial will test whether doxycycline can improve vision in people with neovascular age-related macular degeneration who are incomplete responders to anti-VEGF intravitreal injections.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Doxycycline may cause stomach upset, sun sensitivity, and allergic reactions. Long-term use might lead to yeast infections or changes in blood cell counts. The side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have wet age-related macular degeneration.

Select...

My wet AMD has not improved despite 3 anti-VEGF injections.

Select...

I still have fluid in my retina from wet AMD despite 3 anti-VEGF injections.

Select...

I have wet age-related macular degeneration.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months and 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months and 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months and 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Change in best corrected visual acuity (BCVA)

Change in optical coherence tomography (OCT) central media thickness (CMT)

Inflammatory mediators matrix metalloproteinases MMP-9 and MMP-9 activity

+1 more

Other outcome measures

Ocular Adverse Events

Systemic Adverse Events

Side effects data

From 2021 Phase 4 trial • 22 Patients • NCT05399290

Photoallergic reaction

100%

80%

60%

40%

20%

Study treatment Arm

100 mg Standard Dose Doxycycline BID

20 mg Sub-antimicrobial Dose Doxycycline BID

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: DoxycyclineExperimental Treatment1 Intervention

Participants received doxycycline hyclate 50 mg capsule orally once a day for 6 months

Group II: PlaceboPlacebo Group1 Intervention

Participants received placebo (inactive) capsule orally once a day for 6 months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxycycline Hyclate

2020

Completed Phase 4

~30

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of IowaLead Sponsor

446 Previous Clinical Trials

879,452 Total Patients Enrolled

Elliott H Sohn, MDPrincipal InvestigatorUniversity of Iowa

Media Library

Doxycycline Hyclate Clinical Trial Eligibility Overview. Trial Name: NCT04504123 — Phase 2

Age-Related Macular Degeneration Research Study Groups: Placebo, Doxycycline

Age-Related Macular Degeneration Clinical Trial 2023: Doxycycline Hyclate Highlights & Side Effects. Trial Name: NCT04504123 — Phase 2

Doxycycline Hyclate 2023 Treatment Timeline for Medical Study. Trial Name: NCT04504123 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age criterion for this investigation limited to individuals under 65?

"This medical trial is restricted to individuals aged 50 to 99. The total number of trials for patients under 18 is 21 while those over 65 have 205 opportunities available."

Answered by AI

Has Doxycycline Hyclate received regulatory approval from the US Food and Drug Administration?

"Data supporting the safety of Doxycycline Hyclate is present, but efficacy data remains unverified; hence it receives a score of 2."

Answered by AI

What are the qualifications for eligibility in this medical experiment?

"To qualify for this medical trial, participants must be between the ages of 50 and 99 with a diagnosis of wet macular degeneration. All told, only fifty people will take part in this clinical research."

Answered by AI

What medical problems is Doxycycline Hyclate typically prescribed to address?

"Doxycycline Hyclate is a viable option to address the symptoms of tularemia, relapsing fever caused by borrelia recurrentis and rickettsialpox."

Answered by AI

Are there any vacancies available to partake in this clinical experiment?

"Affirmative. Clinicaltrials.gov has published that this research endeavor, which was initially posted on November 4th 2020, is actively looking for participants. The trial needs to recruit 50 people from a single site."

Answered by AI

What is the number of participants in this clinical examination?

"Indeed. Details provided on clinicaltrials.gov indicate that the trial, which was initiated on November 4th 2020, is presently enrolling participants. 50 volunteers are being sought from 1 unique site of enrolment."

Answered by AI