Minocycline Treatment in Retinitis Pigmentosa

Retinitis Pigmentosa Clinical Trial

Official title:

The Efficacy and Safety of Oral Minocycline in the Treatment of Retinitis Pigmentosa: An Open-label Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04068207
• Other study ID #: 5010-MINO-RP
• Status: Completed
• Phase: Phase 2
• Start date: August 25, 2019
• Est. completion date: December 1, 2023

Study information

• Verified date: April 2023
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 1, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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) 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.

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.

Related Conditions & MeSH terms

• Inherited Retinal Dystrophy
• Retina Disorder
• Retinal Diseases
• Retinal Dystrophies
• Retinitis
• Retinitis Pigmentosa

Intervention

Drug:
• Minocycline
Tab. Minocycline 100mg po per day for 12 months

Locations

Country	Name	City	State
China	Zhongshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of full-field cone electroretinogram amplitude to 30-Hz flashes	increase of full-field cone electroretinogram amplitude to 30-Hz flashes	12 months, 24 weeks
Secondary	change of visual field area	HFA30-2 and HFA60-4	12 months, 24 weeks
Secondary	Best Corrected Visual Acuity	increase of BCVA	12 months, 24 weeks
Secondary	other ERG indexes	ERG indexes	12 months, 24 weeks
Secondary	color vision	Farnsworth-Munsell 100-hue test (FM-100)	12 months, 24 weeks
Secondary	Contrast sensitivity	Functional Acuity Contrast Test (FACT)	12 months, 24 weeks
Secondary	central foveal thickness	central foveal thickness via OCT	12 months, 24 weeks