Cortical Visual ImpairmentNCT07492966
Exosomes Effect on Visual Function in CVI
An observational study of Cortical Visual Impairment and Visual Function, run by Hatice Semrin Timlioglu İper at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn about the effects of nazally applied exosome treatment on visual functions in children with Phase 1 Cerebral visual impairment (CVİ). Read more about this study
- Who is it for?
- Ages 12 to 34 months
- Conditions the study is for
- Cortical Visual Impairment, Visual Function
- What is being tested?
- Molecularly matched therapy
- Type of treatment
- Injection or infusion
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2024to 24 Sep 2025
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 34 months
- All sexes
- No healthy volunteers
- Child
Study population: The study population consisted of pediatric patients aged 12-34 months who dere diagnosed with Phase 1 CVI and SP and who were referred to the Zatay Pediatric Neurology Clinic. All participants recieved exosome therapy 4-6 times over a 12 month period, administered monthly.
Who may be able to join
- Phase I Cerebral Palsy and Cortical Visual Impairment
- During the 12 months period recieved 4-6 times intranasal exosome
Who cannot join
- Irregular follow-up
- Abondened the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Nasal Mesenchymal Exosome Administration on Vision Function in CVI
The goal of this observational study is to learn about the effects of nazally applied exosome treatment on visual functions in children with Phase 1 Cerebral visual impairment (CVİ).
The main question it aims to answer is:
Read more
Does exosome therapy administered via the nasal route for neurological disorders in children with Phase 1 CVI also show a beneficial effect on visual functions? Researchers will compare visual and visual function findings before and after the exosome application to determine whether the exosome application is also effective in visual function.
Participants:
- They will receive exosomes via the nasal route every month for 6 months.
- They will visit the clinic every month for monitoring and tests.
Read the detailed description
Purpose Cortical visual impairment (CVI) denotes a pediatric visual deficit arising from non-ocular etiologies, purportedly linked to perturbations in visual cortical processing regions. This syndrome characteristically ensues from perinatal insults-such as asphyxia, prematurity, neonatal hypoglycemia, or hypoxia-inflicting damage upon retro-geniculate visual pathways and cortical centers. Empirical evidence underscores cerebral neuroplasticity, facilitating reorganization despite congenital retro-geniculate lesions; nonetheless, CVI manifests heterogeneous visual and cognitive sequelae. With 17% of neonates necessitating intensive care, advancements in neonatal care have augmented survival, concomitantly escalating the prevalence of neurodevelopmental disorders including CVI and cerebral palsy (CP), thereby spurring investigational reparative modalities such as stem cell and molecular therapeutics.
Methods This investigation prospectively enrolled 32 children aged 0.6-13 years diagnosed with CVI, who received intranasal exosome therapy (5 × 10^6 particles/dose) between 2023 and 2024. Administration occurred in 4-6 iterations at monthly intervals. Comprehensive neuro-ophthalmic evaluations encompassed dynamic retinoscopy, preferential looking assessments (LEA and Cardiff cards) for visual acuity and Visual Function Index, alongside surveillance of ventral stream deficits (e.g., delayed gaze, complexity aversion) and dorsal stream impairments (e.g., visuomotor orienting). Statistical analyses employed IBM SPSS Statistics version 25.0 (IBM Corp., Armonk, NY, USA).
- Conditions
- Cortical Visual Impairment, Visual Function
- Being tested
- Molecularly matched therapy
- Keywords
- Cortical Visual Impairment, Visual Function, Nasal Mesenchymal Exosome, Exosome
- Medical subject headings
- Blindness, Cortical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Molecularly matched therapyOther
Derived from mesenchymal stem cells, exosomes are nano-scale vesicles characterized by their regenerative and anti-inflammatory capabilities. These vesicles can traverse the blood-brain barrier to transport functional cargo, including lipids, mRNA, and proteins, to target cells. Over the course of 12 months, volunteers were administered 5 million units of exosomes in 7 ml via nasal spray once a month for a total of 4-6 doses, with an infusion rate of 1 ml per hour.
| Study group | Role | What they receive |
|---|---|---|
| study group | The cohort comprised 32 pediatric volunteers aged 12-34 months diagnosed with Phase 1 cortical visual impairment (CVI) concomitant with simultaneous perception (SP) deficit at Zatay Paediatric Neurology Clinic between June 2024 and July 2025. All participants underwent intranasal exosome therapy administered in 4-6 monthly doses over a 12-month surveillance interval.
Data were prospectively accrued via clinical files and serial neuro-ophthalmic examination records, with comprehensive follow-up spanning 12 months to delineate therapeutic trajectory and neuroplastic adaptations. Receives: Other: Molecularly matched therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether exosome therapy combined with standardized neuro-visual rehabilitation improves functional vision outcomes compared to rehabilitation plus placebo.
Change in Visual Function Index (VFI) total score
The total score for visual function is 15, comprising the sum of 13 functions, each worth 1 point, and fixation, which is worth 2 points. Missing functions are scored as 0.
Measured: Up to 1 year
Primary Objective ( Safety)
To evaluate the advers effects of repeated intranasal exosome administration in pediatric patients with CVI over a 12-week treatment period.
Epileptic attack Allergic reactions Treatment discontinuation due to adverse events
Measured: Up to 1 year
Affected Visual fields (Totally impaired /delayed)
Impaired Visual Field Before, n (%) 0/1
Measured: Up to 1 year
Secondary outcomes (1)
Exploratory Objectives (Neuroplasticity Mechanisms)
Quantification of "Delayed Field → Functional Field" transition rate
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start30 Jun 2024
- Primary completion19 Jul 2025
- Study completion24 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cortical Visual ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 32 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Hatice Semrin Timlioglu İper
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hatice Semrin Timlioglu İper, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492966
- Sponsor's protocol ID
- 2025/12-05
- Status last verified
- Mar 2026
- First submitted
- 8 Feb 2026
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Nasal Mesenchymal Exosome Administration on Vision Function in CVI
- ClinicalTrials.gov ID
- NCT07492966
- Acronym / sponsor ID
- 2025/12-05
- Conditions
- Cortical Visual Impairment, Visual Function
- Keywords
- Cortical Visual Impairment, Visual Function, Nasal Mesenchymal Exosome, Exosome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hatice Semrin Timlioglu İperUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 19 Jul 2025 (actual)
- Study completion
- 24 Sep 2025 (actual)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the effects of nazally applied exosome treatment on visual functions in children with Phase 1 Cerebral visual impairment (CVİ).
The main question it aims to answer is:
Does exosome therapy administered via the nasal route for neurological disorders in children with Phase 1 CVI also show a beneficial effect on visual functions? Researchers will compare visual and visual function findings before and after the exosome application to determine whether the exosome application is also effective in visual function.
Participants:
- They will receive exosomes via the nasal route every month for 6 months.
- They will visit the clinic every month for monitoring and tests.
Detailed description
Purpose Cortical visual impairment (CVI) denotes a pediatric visual deficit arising from non-ocular etiologies, purportedly linked to perturbations in visual cortical processing regions. This syndrome characteristically ensues from perinatal insults-such as asphyxia, prematurity, neonatal hypoglycemia, or hypoxia-inflicting damage upon retro-geniculate visual pathways and cortical centers. Empirical evidence underscores cerebral neuroplasticity, facilitating reorganization despite congenital retro-geniculate lesions; nonetheless, CVI manifests heterogeneous visual and cognitive sequelae. With 17% of neonates necessitating intensive care, advancements in neonatal care have augmented survival, concomitantly escalating the prevalence of neurodevelopmental disorders including CVI and cerebral palsy (CP), thereby spurring investigational reparative modalities such as stem cell and molecular therapeutics.
Methods This investigation prospectively enrolled 32 children aged 0.6-13 years diagnosed with CVI, who received intranasal exosome therapy (5 × 10^6 particles/dose) between 2023 and 2024. Administration occurred in 4-6 iterations at monthly intervals. Comprehensive neuro-ophthalmic evaluations encompassed dynamic retinoscopy, preferential looking assessments (LEA and Cardiff cards) for visual acuity and Visual Function Index, alongside surveillance of ventral stream deficits (e.g., delayed gaze, complexity aversion) and dorsal stream impairments (e.g., visuomotor orienting). Statistical analyses employed IBM SPSS Statistics version 25.0 (IBM Corp., Armonk, NY, USA).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Other: Molecularly matched therapyThe cohort comprised 32 pediatric volunteers aged 12-34 months diagnosed with Phase 1 cortical visual impairment (CVI) concomitant with simultaneous perception (SP) deficit at Zatay Paediatric Neurology Clinic between June 2024 and July 2025. All participants underwent intranasal exosome therapy administered in 4-6 monthly doses over a 12-month surveillance interval. Data were prospectively accrued via clinical files and serial neuro-ophthalmic examination records, with comprehensive follow-up spanning 12 months to delineate therapeutic trajectory and neuroplastic adaptations. |
Who may qualify
- Ages
- 12 to 34 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consisted of pediatric patients aged 12-34 months who dere diagnosed with Phase 1 CVI and SP and who were referred to the Zatay Pediatric Neurology Clinic. All participants recieved exosome therapy 4-6 times over a 12 month period, administered monthly.
Key inclusion criteria (2 listed)
- Phase I Cerebral Palsy and Cortical Visual Impairment
- During the 12 months period recieved 4-6 times intranasal exosome
Key exclusion criteria (2 listed)
- Irregular follow-up
- Abondened the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Molecularly matched therapyDerived from mesenchymal stem cells, exosomes are nano-scale vesicles characterized by their regenerative and anti-inflammatory capabilities. These vesicles can traverse the blood-brain barrier to transport functional cargo, including lipids, mRNA, and proteins, to target cells. Over the course of 12 months, volunteers were administered 5 million units of exosomes in 7 ml via nasal spray once a month for a total of 4-6 doses, with an infusion rate of 1 ml per hour. | Other | study group |
Primary outcome
Whether exosome therapy combined with standardized neuro-visual rehabilitation improves functional vision outcomes compared to rehabilitation plus placebo.
Time frame: Up to 1 year
Change in Visual Function Index (VFI) total score The total score for visual function is 15, comprising the sum of 13 functions, each worth 1 point, and fixation, which is worth 2 points. Missing functions are scored as 0.
Primary Objective ( Safety)
Time frame: Up to 1 year
To evaluate the advers effects of repeated intranasal exosome administration in pediatric patients with CVI over a 12-week treatment period. Epileptic attack Allergic reactions Treatment discontinuation due to adverse events
Affected Visual fields (Totally impaired /delayed)
Time frame: Up to 1 year
Impaired Visual Field Before, n (%) 0/1
1 secondary outcome
Exploratory Objectives (Neuroplasticity Mechanisms)
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Current Modalities for Low Vision RehabilitationLink provided by the sponsor.
- Recent Advances in Extracellular Vesicle-Based Therapies Using Induced Pluripotent Stem Cell-Derived Mesenchymal Stromal CellsLink provided by the sponsor.
- Extracellular vesicle-based therapy application and efficacy in ophthalmic diseases: from origin to targetLink provided by the sponsor.
- Extracellular vesicles as a new horizon in the diagnosis and treatment of inflammatory eye diseases: A narrative review of the literatureLink provided by the sponsor.
- Safety and efficacy outcomes after intranasal administration of neural stem cells in cerebral palsy: a randomized phase 1/2 controlled trialLink provided by the sponsor.
- Mesenchymal stem cell-derived exosomes therapy: research progress and mechanism of actionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cortical Visual Impairment and Visual Function, run by Hatice Semrin Timlioglu İper at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Whether exosome therapy combined with standardized neuro-visual rehabilitation improves functional vision outcomes compared to rehabilitation plus placebo. (time frame: Up to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.