Retinitis PigmentosaPhase 2NCT04068207
Minocycline Treatment in Retinitis Pigmentosa
A Phase 2 study testing Minocycline in people with Retinitis Pigmentosa and Inherited Retinal Dystrophy, run by Sun Yat-sen University at 1 site in China.
Trial summary
The aim of this study is to evaluate the efficacy and safety of oral minocycline (100mg/d), administered for 6 months, for the treatment of patients with retinitis pigments(RP). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Retinitis Pigmentosa, Inherited Retinal Dystrophy, Retina Disorder
- 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
- 35 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2019to 1 Dec 2023
- Phase
- Phase 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of Retinitis Pigmentosa: nyctalopia, visual field constriction and loss of central vision; degeneration of peripheral rod photoreceptor and retinal pigment epithelium cells.
- Age from 18 to 60 years old.
- BCVA >20/100(0.2) at least in one eye.
- Full-field cone electroretinogram amplitude to 30-Hz flashes >0uV at least in one eye.
- Written informed consent is provided.
Who cannot join
- Glucocortticoids or tetracycline were used within 3 months.
- Vitamin A, DHA and other neurotrophic drugs were used within 3 months.
- Other ocular diseases or fundus diseases except cataract: glaucoma, diabetic retinopathy, retinal detachment.
- Tetracycline or minocycline allergy or intolerance.
- Renal or hepatic insufficiency.
- History of thyroid neoplasm.
- History of idiopathic intracranial hypertension.
- Pregnant or lactating females.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: The Efficacy and Safety of Oral Minocycline in the Treatment of Retinitis Pigmentosa: An Open-label Clinical Trial
The aim of this study is to evaluate the efficacy and safety of oral minocycline (100mg/d), administered for 6 months, for the treatment of patients with retinitis pigments(RP).
Read the detailed description
Retinitis Pigmentosa (RP)is a sort of inherited blinding disorders and no effective or safe treatment are widely applied for it. The worldwide prevalence of RP is estimated to be 1/5000. RP is characterized by degeneration of peripheral rod photoreceptor(PR) and associated retinal pigment epithelium(RPE) cells. Nyctalopia and visual field constriction are common symptoms. Cone degeneration and associated loss of central vision are typically followed later.
Minocycline, a secord-generation, semi-synthetic tetracycline antibiotic, is a highly lipophilic molecule and can easily pass through the blood-brain barrier. Several animal experiments and clinical trials have reported that minocycline exert anti-apoptotic, anti-inflammatory and antioxidant effects in treating neurodegenerative diseases.
We propose to test the effect and safety of oral minocycline for retinitis pigmentosa.
- Being tested
- Minocycline
- Keywords
- Retinitis Pigmentosa, Minocycline, ERG, Inherited Retinal Dystrophy, Retinal Degenerative Disease
- Medical subject headings
- Retinitis Pigmentosa, Retinal Diseases, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
Also called Minocin, Minocyclinum, Minocyclin
Tab. Minocycline 100mg po per day for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Minocycline | Experimental | Tablets Minocycline 100mg po per day for 12 months Receives: Drug: Minocycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of full-field cone electroretinogram amplitude to 30-Hz flashes
increase of full-field cone electroretinogram amplitude to 30-Hz flashes
Measured: 12 months， 24 weeks
Secondary outcomes (6)
change of visual field area
HFA30-2 and HFA60-4
Measured: 12 months， 24 weeks
Best Corrected Visual Acuity
increase of BCVA
Measured: 12 months， 24 weeks
other ERG indexes
ERG indexes
Measured: 12 months， 24 weeks
color vision
Farnsworth-Munsell 100-hue test (FM-100)
Measured: 12 months， 24 weeks
Contrast sensitivity
Functional Acuity Contrast Test (FACT)
Measured: 12 months， 24 weeks
central foveal thickness
central foveal thickness via OCT
Measured: 12 months， 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start25 Aug 2019
- Primary completion31 Jan 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinitis PigmentosaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
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, MD, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04068207
- Sponsor's protocol ID
- 5010-MINO-RP
- Status last verified
- Apr 2023
- First submitted
- 23 Aug 2019
- Last updated
- 27 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen Y, Pan Y, Xie Y, Shi Y, Lu Y, Xia Y, Su W, Chen X, Li Z, Wang M, Miao S, Yang Y, Jin C, Luo G, Long S, Xiao H, Huang C, Zhang J, Liang D. Efficacy and safety of minocycline in retinitis pigmentosa: a prospective, open-label, single-arm trial. Signal Transduct Target Ther. 2024 Dec 4;9(1):339. doi: 10.1038/s41392-024-02037-2.
PubMed 39627217
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Oral Minocycline in the Treatment of Retinitis Pigmentosa: An Open-label Clinical Trial
- ClinicalTrials.gov ID
- NCT04068207
- Acronym / sponsor ID
- 5010-MINO-RP
- Keywords
- Retinitis Pigmentosa, Minocycline, ERG, Inherited Retinal Dystrophy, Retinal Degenerative Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 25 Aug 2019 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 28 Aug 2019 (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.
The aim of this study is to evaluate the efficacy and safety of oral minocycline (100mg/d), administered for 6 months, for the treatment of patients with retinitis pigments(RP).
Detailed description
Retinitis Pigmentosa (RP)is a sort of inherited blinding disorders and no effective or safe treatment are widely applied for it. The worldwide prevalence of RP is estimated to be 1/5000. RP is characterized by degeneration of peripheral rod photoreceptor(PR) and associated retinal pigment epithelium(RPE) cells. Nyctalopia and visual field constriction are common symptoms. Cone degeneration and associated loss of central vision are typically followed later.
Minocycline, a secord-generation, semi-synthetic tetracycline antibiotic, is a highly lipophilic molecule and can easily pass through the blood-brain barrier. Several animal experiments and clinical trials have reported that minocycline exert anti-apoptotic, anti-inflammatory and antioxidant effects in treating neurodegenerative diseases.
We propose to test the effect and safety of oral minocycline for retinitis pigmentosa.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Minocycline | Experimental | Drug: MinocyclineTablets Minocycline 100mg po per day for 12 months |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Clinical diagnosis of Retinitis Pigmentosa: nyctalopia, visual field constriction and loss of central vision; degeneration of peripheral rod photoreceptor and retinal pigment epithelium cells.
- Age from 18 to 60 years old.
- BCVA >20/100(0.2) at least in one eye.
- Full-field cone electroretinogram amplitude to 30-Hz flashes >0uV at least in one eye.
- Written informed consent is provided.
Key exclusion criteria (8 listed)
- Glucocortticoids or tetracycline were used within 3 months.
- Vitamin A, DHA and other neurotrophic drugs were used within 3 months.
- Other ocular diseases or fundus diseases except cataract: glaucoma, diabetic retinopathy, retinal detachment.
- Tetracycline or minocycline allergy or intolerance.
- Renal or hepatic insufficiency.
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 |
|---|---|---|
| MinocyclineAlso: Minocin, Minocyclinum, MinocyclinTab. Minocycline 100mg po per day for 12 months | Drug | Minocycline |
Primary outcome
change of full-field cone electroretinogram amplitude to 30-Hz flashes
Time frame: 12 months， 24 weeks
increase of full-field cone electroretinogram amplitude to 30-Hz flashes
6 secondary outcomes
change of visual field area
Time frame: 12 months， 24 weeks
Best Corrected Visual Acuity
Time frame: 12 months， 24 weeks
other ERG indexes
Time frame: 12 months， 24 weeks
color vision
Time frame: 12 months， 24 weeks
Contrast sensitivity
Time frame: 12 months， 24 weeks
central foveal thickness
Time frame: 12 months， 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Derived from this study: PubMed 39627217Chen Y, Pan Y, Xie Y, Shi Y, Lu Y, Xia Y, Su W, Chen X, Li Z, Wang M, Miao S, Yang Y, Jin C, Luo G, Long S, Xiao H, Huang C, Zhang J, Liang D. Efficacy and safety of minocycline in retinitis pigmentosa: a prospective, open-label, single-arm trial. Signal Transduct Target Ther. 2024 Dec 4;9(1):339. doi: 10.1038/s41392-024-02037-2.
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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. This study is not recruiting at the moment.
Dan Liang, MD 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 2 study testing Minocycline in people with Retinitis Pigmentosa and Inherited Retinal Dystrophy, 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 5 inclusion and 8 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: finished, as of the sponsor's last update on 27 Dec 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 phase mean?
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of full-field cone electroretinogram amplitude to 30-Hz flashes (time frame: 12 months， 24 weeks). 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 NCT04068207, 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 27 Dec 2023.