Trials Sponsors Conditions Drugs Pricing

Conditions

X-linked Retinoschisis

Outcome Measures

Primary Outcomes (2)

Incidence of adverse events (AEs)
Incidence of adverse events (AEs) within 24 weeks of LX103 intravitreal injection at different doses
24 weeks
Incidence of serious adverse events (SAEs)
Incidence of serious adverse events (SAEs) within 24 weeks of LX103 intravitreal injection at different doses
24 weeks

Secondary Outcomes (3)

Mean change from baseline in BCVA (LogMAR) in the study eye
24 weeks, 52 weeks
Mean change from baseline in central subfield thickness (CST) in the study eye
24 weeks, 52 weeks
Change from baseline in Electroretinogram (ERG) parameters in the study eye
24 weeks, 52 weeks

Study Arms (1)

LX103 Injection

EXPERIMENTAL

Potential doses: 5E10 vg, 0.1 mL/eye/dose (low dose) 1E11 vg, 0.05 mL/eye/dose (high dose)

Genetic: LX103 Injection

Interventions

LX103 InjectionGenetic

Qualified subjects will receive a single unilateral intravitreal injection of LX103 at Day 0 in the trial.

LX103 Injection

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age6 Years+

Sexmale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

Willing to sign the informed consent, and willing to attend follow-up visits.
Male individual at least 6 years of age with a diagnosis of XLRS and documented mutations in the RS1 gene.

Sponsors & Collaborators

Innostellar Biotherapeutics
Type not reportedcollaborator
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Otherlead

Study Sites (1)

Shanghai General Hospital, Shanghai Jiao Tong University

Shanghai, 200080, China

RECRUITING

Junran Sun, MDCONTACT+86 13661995933 emiliesun@sina.com

Xiaodong Sun, PhDPRINCIPAL INVESTIGATOR

MeSH Terms

Conditions

Retinoschisis

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: PhD

Study Record Dates

First Submitted

April 4, 2023

First Posted

April 18, 2023

Study Start

December 13, 2022

Actual (reported)

Primary Completion

August 2024

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Safety and Efficacy Study of LX103 Treatment of X-Linked Retinoschisis (XLRS)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

LX103 Injection

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (3)

Study Arms (1)

LX103 Injection

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations