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Retinoschisis clinical trials

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NCT ID: NCT06345898 Recruiting - Clinical trials for X Linked Retinoschisis

Safety and Efficacy of a Single Subretinal Injection of JWK002 Gene Therapy in Subjects With X-linked Retinoschisis(XLRS)

Start date: November 17, 2023
Phase: Early Phase 1
Study type: Interventional

This trial is to evaluate the safety and efficacy of JWK002 treatment of X-linked retinoschisis(XLRS). This study will enroll subjects aged 5-18 years old to receive a sub-retinal injection of JWK002.

NCT ID: NCT06289452 Recruiting - Eye Diseases Clinical Trials

Safety and Efficacy Study of IVB102 Injection in Subjects With X-linked Retinoschisis

Start date: March 8, 2024
Phase: Early Phase 1
Study type: Interventional

The goal of this clinical trial is to evaluate the safety and efficacy of IVB102 injection in subjects with XLRS.

NCT ID: NCT06114537 Recruiting - Retinoschisis Clinical Trials

The AXIS Study: the Efficacy of Acetazolamide for the Treatment of Cystoid Fluid Collections in Retinoschisis

AXIS
Start date: January 20, 2023
Phase: Phase 2
Study type: Interventional

X-linked retinoschisis (XLRS) is a rare hereditary eye disease that causes irreversible vision loss in boys and young men. This disease occurs in 1 in 10,000-30,000. This inherited condition is caused by pathogenic variants in a single gene, namely the Retinoschisin 1 (RS1). This gene encodes the retinoschisin protein. Pathological variants of retinoschisin lead to loss of retinal integrity, resulting in the characteristic cystoid fluid collections (CFC). From a young age, XLRS patients experience a gradual deterioration of vision. In middle-aged patients however, XLRS may be associated with macular atrophy because of the confluence of the cystoid lesions. No permanent treatment is yet available for XLRS patients. Currently, two different phase I/II studies are investigating the safety and effectivity of subretinal gene therapy. To create optimal retinal condition before gene therapy, CFC, a hallmark of XLRS, should not be present. Topical and oral carbonic anhydrase II inhibitors are used to combat CME. This drug is still off-label prescribed for various hereditary retinal dystrophies. Consequently, there is no treatment regimen for prescribing acetazolamide to XLRS patients. A thorough understanding of the safety and efficacy of acetazolamide in reducing the central foveal thickness in XLRS patients is required before applying future gene therapy. The proposed study is a investigator-initiated, single-center, prospective, experimental study consisting of seven visits at 2, 4, 12, 16, 20 and 32 weeks after the baseline evaluation visit. During each visit, participants will perform several ophthalmological measurements. In this study, participants with XLRS will be randomized into either a treatment or control group. The null-hypothesis of this study is that acetazolamide effectively reduces the central foveal thickness in patients with XLRS and significantly improves their visual function. The alternative hypothesis is that acetazolamide reduces not effectively the central foveal thickness in patients with XLRS and has no significant impact on their visual function. Treatment success will be based not only on anatomical improvement, but also on functional endpoints, which are most important from a patient's perspective. The study will last 32 weeks per participant. Each participant will come physically for seven visits. The whole study will last for max. 24 months. The examinations and number of visits are reduced to a minimum. In contrast to clinical care, the participants receive examinations that consist of a more extensive measurement of visual acuity, microperimetry and a questionnaire. These extra examinations are required to evaluate the functional vision-related endpoints of the study.

NCT ID: NCT06066008 Recruiting - Clinical trials for X-linked Retinoschisis

Safety and Efficacy Study of Novel Gene Therapy ZM-01 for X-linked Retinoschisis Patients

Start date: September 25, 2022
Phase: Early Phase 1
Study type: Interventional

This trial is meant to evaluate the safety and efficacy of ZM-01 of X-linked retinoschisis. Unilateral intravitreal injections (IVT) will be given into the subject's Study Eye.

NCT ID: NCT05878860 Recruiting - Clinical trials for X-linked Retinoschisis

ATSN-201 Gene Therapy in RS1-Associated X-linked Retinoschisis

LIGHTHOUSE
Start date: August 22, 2023
Phase: Phase 1/Phase 2
Study type: Interventional

This study will evaluate the safety and tolerability of ATSN-201 in male subjects ≥ 6 years of age with RS1-associated X-linked retinoschisis (XLRS).

NCT ID: NCT05814952 Recruiting - Clinical trials for X-linked Retinoschisis

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

Start date: December 13, 2022
Phase: N/A
Study type: Interventional

The goal of this study is to evaluate the safety and efficacy of LX103 treatment of X-linked retinoschisis. This study will enroll subjects aged ≥ 6 years old to receive a single unilateral intravitreal (IVT) injection of LX103 to evaluate its safety and efficacy.

NCT ID: NCT03586193 Recruiting - Retinal Disease Clinical Trials

Pars Plana Vitrectomy Alone in the Treatment of Macular Schisis in High Myopic Eyes

Start date: May 1, 2018
Phase:
Study type: Observational

High myopic schisis (HMF) has the clinical feature of separation between retinal layers. It is sometimes accompanied with foveal retinal detachment, macular lamellar hole, epiretinal membrane and vitreous retraction. HMF may develop to macular hole, macular detachment and will damage the visual function. Pars plana vitrectomy (PPV) is a commonly used surgery in the treatment of HMF. PPV together with internal limiting membrane (ILM) peeling and long-term gas tamponade was reported to be safe and effective. But nowadays there was no available long-term gas in our country. Also, whether ILM peeling is necessary remains controversial, Indole cyanine green (ICG)was proved to have potential toxicity to the retina and the ILM peeling has the risk of causing secondary macular hole. We propose to make a prospective nonrandomized controlled study to evaluate the safety and efficiency of using PPV alone in the treatment of HMF.

NCT ID: NCT03354403 Completed - Retinoschisis Clinical Trials

Mothers Experiences With X-linked Retinoschisis Compared to Fathers Experiences

Start date: December 1, 2017
Phase:
Study type: Observational

Background: X-linked retinoschisis (XLRS) is a genetic condition. It usually presents in boys in childhood with vision loss. Genetic conditions affect the people who have it and also their family members. Researchers want to learn if mothers and fathers react differently when a son gets XLRS. They also want to learn how personality impacts the way people react. This will help researchers find better ways to support families living with XLRS. Objective: To learn more about the experiences of mothers of sons with XLRS compared to fathers of sons with XLRS. Also to study personality differences between mothers and fathers. Eligibility: Parents of a biological son of any age with XLRS who is enrolled in protocol 03-EI-0033 Design: Participants will be asked questions in person or by phone. This will last 30 90 minutes. They will be asked about their experience with XLRS and how it has impacted their family. The interview will be recorded. Participants will complete a survey about personality traits. It will be anonymous. It can be completed by mail, email, or fax. It will take about 15 minutes. Participants data may be shared with others, including those not at NIH, if they agree. Their data may be stored. Sponsoring Institution: National Eye Institute

NCT ID: NCT03023800 Completed - High Myopia Clinical Trials

Effects of Macular Buckle Versus Vitrectomy on Macular Schisis and Macular Detachment in Highly Myopic Eyes

Start date: April 2015
Phase: N/A
Study type: Interventional

Macular schisis associated with macular detachment is a one of the complications of high myopia. There is controversy in the primary treatment for this situation. This study will compare the effects of macular buckling + gas injection versus vitrectomy + internal limiting membrane peeling + gas tamponade in a cohort of highly myopic eyes with macular retinal detachment associated with macular schisis.

NCT ID: NCT02682797 Completed - Retinoschisis Clinical Trials

Optical Coherence Tomography Evaluation of Retinoschisis and Retinal Detachment

Start date: September 2013
Phase: N/A
Study type: Observational

Retinoschisis is usually a rare self-limited disease and seldom shows progression. There a splitting of the neurosensory retina occurs usually in the inferior temporal. Patients usually have good visual acuity and are asymptomatic. Combination of an inner and outer layer hole is considered high risk factor for development of a schisis detachment. The most important differential diagnosis is an retinal detachment, since if misdiagnosed unnecessary treatment is provided. In clinical examination, both can appear very thin and transparent. Therefore exact diagnosis of retinoschisis and retinal detachment has to be assessed and regular follow-up controls have to be conducted for sufficient recognition of progression.