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MinocyclinePhase 1/2MINOCMENCT05474950

Minocycline Treatment for Cystoid Macular Edema

A Phase 1/2 study testing minocycline in people with Minocycline and Cystoid Macular Edema, run by Sun Yat-sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Cystoid macular edema (CME) is one of sight-threatening, immune-related ocular diseases. The efficacy of current treatments for CME (anti-VEGF, glucocorticoids and other agents) are limiting. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Minocycline, Cystoid Macular Edema
What is being tested?
minocycline
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteChina
Study dates
1 Jan 2019to 1 Jun 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant diagnosed with CME.
  • Participant aged from 18-60 years old.
  • Participant that signed the informed consent document and is able to complete the following visits.

Who cannot join

  • Participant is allergy to minocycline or tetracyclines.
  • Participant has no contraindications of minocycline or tetracyclines.
  • Participant has an abnormal function of liver, heart, kidney and thyroid.
  • Female that is pregnant, breast-feeding or planning to become pregnant.
  • Participant that is currently using other medications.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Zhongshan Ophthalmic Center

    Guangzhou, Guangdong, 510000

    Dan Liang, （86）-87330402, liangdan@gzzoc.com

    Dan Liang

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of the Treatment of Minocycline for Cystoid Macular Edema

Cystoid macular edema (CME) is one of sight-threatening, immune-related ocular diseases. The efficacy of current treatments for CME (anti-VEGF, glucocorticoids and other agents) are limiting. Minocycline, acting as a broad-spectrum antibiotic, is among tetracycline family and recently, its immunomodulatory and anti-apoptosis function has been replied to several immune diseases and degenerative diseases. This study aims to explore the efficacy and safety of minocycline for CME.

Being tested
minocycline
Medical subject headings
cyclopia sequence, Macular Edema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • minocyclineDrug

    minocycline capsule (100mg) per day orally

Study groups in NCT05474950
Study groupRoleWhat they receive
minocyclineExperimentalNot described
Receives: Drug: minocycline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of cystoid macular edema

    Change of CME measured by Optical coherence tomography (OCT)

    Measured: At 6 months

Secondary outcomes (4)

  1. Change of best corrected visual acuity (BCVA)

    Change of BCVA measured by the Early Treatment Diabetic Retinopathy Study

    Measured: At 6 months

  2. Change of macular sensitivity

    Change of BCVA measured by Macular Integrity Assessment (MAIA)

    Measured: At 6 months

  3. Change of retinal vascular leakage

    Change of retinal vascular leakage measured by Fundus fluorescein angiography (FFA) or indocyanine green angiography (ICGA)

    Measured: At 6 months

  4. Change of macular vessel

    Change of macular vessel measured by optical coherence tomography angiography (OCTA)

    Measured: At 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2022
  2. Study start1 Jan 2019
  3. Primary completion1 Jun 2024 (estimated)
  4. Study completion1 Jun 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05474950
Sponsor's protocol ID
MINOCME
Acronym
MINOCME
Status last verified
Apr 2023
First submitted
23 Jul 2022
Last updated
19 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Romano F, Lamanna F, Gabrielle PH, Teo KYC, Battaglia Parodi M, Iacono P, Fraser-Bell S, Cornish EE, Nassisi M, Viola F, Agarwal A, Samanta A, Chhablani J, Staurenghi G, Invernizzi A. Update on Retinal Vein Occlusion. Asia Pac J Ophthalmol (Phila). 2023 Mar-Apr 01;12(2):196-210. doi: 10.1097/APO.0000000000000598. Epub 2023 Feb 14.

    PubMed 36912792

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing minocycline in people with Minocycline and Cystoid Macular Edema, run by Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change of cystoid macular edema (time frame: At 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05474950, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.

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