MinocyclinePhase 1/2NCT05474729
Minocycline for Chronic Autoimmune Uveitis
A Phase 1/2 study testing minocycline in people with Minocycline and Uveitis, run by Sun Yat-sen University at 1 site in China.
Trial summary
Autoimmune uveitis is one kind of non-infectious, sight-threatening, relapsing and severe ocular disease. Approximately 20%-25% autoimmune uveitis patients suffer from the dilemma of blindness for the chronic and persistent inflammatory state in the eyes, which results in continuous destroy in the structure of the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Minocycline, Uveitis, Retinal Degeneration
- 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
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 31 Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 of autoimmune diseases with visual function damage (decrease of BCVA, loss of retinal structure)
- 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.
- Participant is using glucocorticoids, immunosuppressants or biologics.
- Female that is pregnant, breast-feeding or planning to become pregnant.
- Participant that is currently using other medications for other diseases.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510000
Dan Liang, （86）-87330402, liangdan@gzzoc.com
Dan Liang
About this study
Official title: The Efficacy and Safety of Minocycline for Chronic Autoimmune Uveitis
Autoimmune uveitis is one kind of non-infectious, sight-threatening, relapsing and severe ocular disease. Approximately 20%-25% autoimmune uveitis patients suffer from the dilemma of blindness for the chronic and persistent inflammatory state in the eyes, which results in continuous destroy in the structure of the eyes and gradually leads to irreversible damage on visual function. However, it shows limiting efficacy of current treatment including glucocorticoids, immunosuppressant and biologics for chronic autoimmune uveitis. Minocycline has been regarded to have anti-apoptosis and immunemodulatory function for decades and it has been illustrated to be beneficial in several neuro-degenerative and neuro-inflammatory diseases. This trial aims to investigate the efficacy and safety of minocycline for chronic autoimmune uveitis with retinal degenerative changes.
- Conditions
- Minocycline, Uveitis, Retinal Degeneration
- Being tested
- minocycline
- Medical subject headings
- cyclopia sequence, Uveitis, Retinal Degeneration
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 group | Role | What they receive |
|---|---|---|
| minocycline | Experimental | minocycline capsule 100mg per day orally Receives: Drug: minocycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of macular sensitivity
Change of macular sensitivity measured by MAIA
Measured: At 6 and 12 months
Change of BCVA
Change of BCVA measured by ETDRS
Measured: At 6 and 12 months
Change of Visual field
Change of Visual field measured by HVF 30-2 visual field testing
Measured: At 6 and 12 months
Changes in Implicit Time and Amplitude of Photopic and Scotopic Responses
Changes in Implicit Time and Amplitude of Photopic and Scotopic Responses measured by Electroretinogram (ERG) Testing
Measured: At 6 and 12 months
Secondary outcomes (5)
Change of macular vessel
Change of macular vessel measured by OCTA
Measured: At 6 and 12 months
Change of Contrast Sensitivity
Change of Contrast Sensitivity measured by F.A.C.T
Measured: At 6 and 12 months
Change of Color Visual
Change of Color Visual measured by FM100
Measured: At 6 and 12 months
Change of QoL questionaire
Change of QoL measured by VFI-25
Measured: At 6 and 12 months
Number of ocular and non-ocular adverse events Number of ocular and non-ocular adverse events Number of ocular and non-ocular adverse events Number of ocular and non-ocular adverse events Number of Ocular and Non-ocular Adverse Events
Measured: At 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2022
- Study start1 Dec 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MinocyclineStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Model description
- minocycline capsule
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dan Liang, Sun Yat-sen University
- Investigators
- Dan Liang, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05474729
- Sponsor's protocol ID
- MINOCU
- Status last verified
- Apr 2023
- First submitted
- 24 Jul 2022
- Last updated
- 18 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Minocycline for Chronic Autoimmune Uveitis
- ClinicalTrials.gov ID
- NCT05474729
- Acronym / sponsor ID
- MINOCU
- Conditions
- Minocycline, Uveitis, Retinal Degeneration
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Autoimmune uveitis is one kind of non-infectious, sight-threatening, relapsing and severe ocular disease. Approximately 20%-25% autoimmune uveitis patients suffer from the dilemma of blindness for the chronic and persistent inflammatory state in the eyes, which results in continuous destroy in the structure of the eyes and gradually leads to irreversible damage on visual function. However, it shows limiting efficacy of current treatment including glucocorticoids, immunosuppressant and biologics for chronic autoimmune uveitis. Minocycline has been regarded to have anti-apoptosis and immunemodulatory function for decades and it has been illustrated to be beneficial in several neuro-degenerative and neuro-inflammatory diseases. This trial aims to investigate the efficacy and safety of minocycline for chronic autoimmune uveitis with retinal degenerative changes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- minocycline capsule
| Arm | Type | Receives |
|---|---|---|
| minocycline | Experimental | Drug: minocyclineminocycline capsule 100mg per day orally |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participant diagnosed of autoimmune diseases with visual function damage (decrease of BCVA, loss of retinal structure)
- Participant aged from 18-60 years old.
- Participant that signed the informed consent document and is able to complete the following visits.
Key exclusion criteria (6 listed)
- 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.
- Participant is using glucocorticoids, immunosuppressants or biologics.
- Female that is pregnant, breast-feeding or planning to become pregnant.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| minocyclineminocycline capsule 100mg per day orally | Drug | minocycline |
Primary outcome
Change of macular sensitivity
Time frame: At 6 and 12 months
Change of macular sensitivity measured by MAIA
Change of BCVA
Time frame: At 6 and 12 months
Change of BCVA measured by ETDRS
Change of Visual field
Time frame: At 6 and 12 months
Change of Visual field measured by HVF 30-2 visual field testing
Changes in Implicit Time and Amplitude of Photopic and Scotopic Responses
Time frame: At 6 and 12 months
Changes in Implicit Time and Amplitude of Photopic and Scotopic Responses measured by Electroretinogram (ERG) Testing
5 secondary outcomes
Change of macular vessel
Time frame: At 6 and 12 months
Change of Contrast Sensitivity
Time frame: At 6 and 12 months
Change of Color Visual
Time frame: At 6 and 12 months
Change of QoL questionaire
Time frame: At 6 and 12 months
Number of ocular and non-ocular adverse events Number of ocular and non-ocular adverse events Number of ocular and non-ocular adverse events Number of ocular and non-ocular adverse events Number of Ocular and Non-ocular Adverse Events
Time frame: At 6 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dan Liang principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing minocycline in people with Minocycline and Uveitis, 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 6 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: looking for participants now, as of the sponsor's last update on 18 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dan Liang (（86）-87330402, liangdan@gzzoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of macular sensitivity (time frame: At 6 and 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2023.