Minocycline Treatment in Retinitis Pigmentosa
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ClinicalTrials.gov Identifier: NCT04068207 |
Recruitment Status :
Recruiting
First Posted : August 28, 2019
Last Update Posted : October 1, 2021
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Condition or disease | Intervention/treatment | Phase |
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Retinitis Pigmentosa Inherited Retinal Dystrophy Retina Disorder | Drug: Minocycline | Phase 2 |
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 Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 35 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Efficacy and Safety of Oral Minocycline in the Treatment of Retinitis Pigmentosa: An Open-label Clinical Trial |
Actual Study Start Date : | February 22, 2019 |
Actual Primary Completion Date : | September 1, 2021 |
Estimated Study Completion Date : | December 1, 2023 |

Arm | Intervention/treatment |
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Experimental: Minocycline
Tablets Minocycline 100mg po per day for 24 weeks
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Drug: Minocycline
Tab. Minocycline 100mg po per day for 24 weeks
Other Names:
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- change of full-field cone electroretinogram amplitude to 30-Hz flashes [ Time Frame: 24 weeks ]increase of full-field cone electroretinogram amplitude to 30-Hz flashes
- change of visual field area [ Time Frame: 24 weeks ]HFA30-2 and HFA60-4
- Best Corrected Visual Acuity [ Time Frame: 24 weeks ]increase of BCVA
- central foveal thickness [ Time Frame: 24 weeks ]increase of central foveal thickness

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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).
- Full-field cone electroretinogram amplitude to 30-Hz flashes >0uV.
- Written informed consent is provided.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04068207
Contact: Dan Liang, MD | 0086-20-87330402 | liangd2@mail.sysu.edu.cn |
China, Guangdong | |
Zhongshan Ophthalmic Center, Sun Yat-sen University | Recruiting |
Guangzhou, Guangdong, China, 510060 | |
Contact: Dan Liang, MD 0086-20-87330402 liangd2@mail.sysu.edu.cn | |
Principal Investigator: Dan Liang, MD | |
Zhongshan Ophthalmic Center, Sun Yat-sen University | Recruiting |
Guangzhou, Guangdong, China, 510060 | |
Contact: Dan Liang 0086-20-87330402 liangd2@mail.sysu.edu.cn | |
Principal Investigator: Dan Liang, MD |
Principal Investigator: | Dan Liang, MD | Zhongshan Ophthalmic Center, Sun Yat-sen University |
Responsible Party: | Dan Liang, Lab of ocular immunology in Zhongshan Ophthalmic Center, Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT04068207 |
Other Study ID Numbers: |
5010-MINO-RP |
First Posted: | August 28, 2019 Key Record Dates |
Last Update Posted: | October 1, 2021 |
Last Verified: | February 2021 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Retinitis Pigmentosa Minocycline ERG Inherited Retinal Dystrophy Retinal Degenerative Disease |
Retinitis Retinitis Pigmentosa Retinal Dystrophies Retinal Diseases Eye Diseases Eye Diseases, Hereditary |
Retinal Degeneration Genetic Diseases, Inborn Minocycline Anti-Bacterial Agents Anti-Infective Agents |