Skip to main content
OpenTrials
Completed

NCT Number: NCT07492966

Exosomes Effect on Visual 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:

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cortical Visual Impairment Blindness Blindness, Cortical Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders Visual Function

Age range

12 month–34 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Okan University

Istanbul, Tuzla, Turkey (Türkiye)

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Phase I Cerebral Palsy and Cortical Visual Impairment
  • During the 12 months period recieved 4-6 times intranasal exosome

Exclusion criteria

  • Irregular follow-up
  • Abondened the study

Treatment and study plan

Molecularly matched therapy

Other

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.

Primary outcomes

  1. 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.

  2. 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

  3. Affected Visual fields (Totally impaired /delayed)

    Time frame: Up to 1 year

    Impaired Visual Field Before, n (%) 0/1

Secondary outcomes

  1. Exploratory Objectives (Neuroplasticity Mechanisms)

    Time frame: Up to 1 year

    Quantification of "Delayed Field → Functional Field" transition rate

Other outcomes

  1. Exploratory Objectives (Neuroplasticity Mechanisms)

    Time frame: Up to 1 year

    Learning-curve slope analysis during rehabilitation tasks

Sponsors and collaborators

Lead sponsor

Hatice Semrin Timlioglu İper

Other

Registry information

Official study title

The Effect of Nasal Mesenchymal Exosome Administration on Vision Function in CVI

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 25, 2026
Registry last updated
Mar 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.