A Multicenter, Randomized, Double-Blind, Controlled Clinical Study of Minocycline for the Treatment of Retinitis Pigmentosa

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-60
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University

About this trial

This is a multicenter, double-blind, randomized controlled clinical trial to get high - level evidence on minocycline's efficacy and safety(100mg/d, 200mg/d) for Retinitis pigmentosa and to find the optimal treatment dose.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age should be between 18 and 60 years old.

Clinically diagnosed with retinitis pigmentosa, characterized by reduced electroretinogram (ERG) responses and constricted visual fields.

In at least one eye, the amplitude of the 30Hz flicker ERG under photopic conditions should not be lower than 0 microvolts.

The best-corrected visual acuity (BCVA, ETDRS) in both eyes should not be lower than 0.

Disqualifiers

Allergic to tetracycline antibiotics.

Pregnant or breastfeeding.

Syndromic retinitis pigmentosa.

Currently taking tetracycline antibiotics or any medications that may have adverse interactions with minocycline.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Minocycline 100mg

    Drug

    Capsules Minocycline 100mg po per day and placebo 100mg po per day for 12 months

  • Minocycline 200mg

    Drug

    Capsules Minocycline 100mg po twice a day for 12 months

  • Placebo

    Drug

    Capsules placebo 100mg po twice a day for 12 months

Treatment groups

126 Participants
are divided into 3 treatment groups
Group A: Minocycline 100mgExperimental treatment 1 intervention
Group B: Minocycline 200mgExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The change of ERG

The proportion of patients in the group who showed an increase in the amplitude of the light-adapted 30Hz flicker ERG response at 12 months post-treatment compared to baseline.

Time frame
12 months

Secondary outcomes

1

The change of BCVA

The proportion of patients in this group showing an increase from baseline at month 12 of treatment.

Time frame
12 months
2

The change of VF

The proportion of patients in this group showing an increase from baseline at month 12 of treatment.

Time frame
12 months
3

The change of color vision

The proportion of patients in this group showing an increase from baseline at month 12 of treatment.

Time frame
12 months
4

The change of microperimetry

The proportion of patients in this group showing an increase from baseline at month 12 of treatment.

Time frame
12 months

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: