Fellow-eye Study (FE) of LX101 in Subjects With Inherited Retinal

Clinical Trial Summary

Up to nine subjects who have participated in the earlier LX101 clinical study, and who meet all study eligibility criteria, will receive LX101 administration in the previously uninjected, contralateral eye to evaluate the safety of bilateral, sequential subretinal administration of LX101.

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05976139` - Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies	N/A
Recruiting	`NCT05793515` - Mechanisms of Inherited Retinal Dystrophies Using Whole Genome Sequencing and in Vitro and in Vivo Models
Completed	`NCT04068207` - Minocycline Treatment in Retinitis Pigmentosa	Phase 2
Completed	`NCT04224207` - Management of Retinitis Pigmentosa by Mesenchymal Stem Cells by Wharton's Jelly Derived Mesenchymal Stem Cells	Phase 3

See also

Status

Clinical Trial

Phase

Recruiting

NCT05976139 - Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies

N/A

Recruiting

NCT05793515 - Mechanisms of Inherited Retinal Dystrophies Using Whole Genome Sequencing and in Vitro and in Vivo Models

Completed

NCT04068207 - Minocycline Treatment in Retinitis Pigmentosa

Phase 2

Completed

NCT04224207 - Management of Retinitis Pigmentosa by Mesenchymal Stem Cells by Wharton's Jelly Derived Mesenchymal Stem Cells

Phase 3

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT06212297
Study type	Interventional
Source	Innostellar Biotherapeutics Co.,Ltd
Contact
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	September 12, 2023
Completion date	March 2029

Fellow-eye Study (FE) of LX101 in Subjects With Inherited Retinal Dystrophy

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms