Active — Not RecruitingPhase 2

A Study Comparing Two Doses of AGTC-501 in Male Subjects With X-linked Retinitis Pigmentosa Caused by RPGR Mutations (SKYLINE)

United States14 participantsStarted 2021-04-13

Plain-language summary

This study will evaluate the safety and efficacy of a recombinant adeno-associated virus vector (rAAV2tYF-GRK1-RPGR) in patients with X-linked retinitis pigmentosa caused by RPGR mutations.

Who can participate

Age range8 Years – 50 Years

SexMALE

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Exclusion criteria

✕. Have history of oral or genital herpes and unable and/or unwilling to utilize prophylactic antiviral medication.
✕. Have a history of ocular herpes.
✕. Have active oral or genital herpes or are currently receiving treatment for HSV infection.

What they're measuring

The difference in the proportion of responding eyes between treated and control eyes in the low dose group and high dose group at 12 months, as measured by MAIA microperimetry, where response is defined as a 7dB or more improvement in at least 5 loci.

Timeframe: Day 0 - Month 12

Trial details

NCT IDNCT06333249

SponsorBeacon Therapeutics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-04-11

View on ClinicalTrials.gov More X-Linked Retinitis Pigmentosa trials