Bullous KeratopathyPhase 1NCT07711561
Simple Non-cultured Endothelial Cell Therapy for Corneal Endothelial Dysfunction
A Phase 1 study testing Cell injection in people with Bullous Keratopathy and Corneal Endothelial Dystrophy, run by Singapore Eye Research Institute at 1 site in India.
Trial summary
Assessment of safety and efficacy of cell injection therapy generated using non-cultured human corneal endothelial cells in treating corneal endothelial dysfunction Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bullous Keratopathy, Corneal Endothelial Dystrophy
- What is being tested?
- Cell injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndia
- Study dates
- 22 Jun 2026to Jul 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have mild to moderate corneal endothelial decompensation or bullous keratopathy, but with minimal corneal stromal scarring resulting from irreversible post-surgical corneal decompensation, specifically, all forms of pseudophakic or aphakic bullous keratopathy.
Who cannot join
- Severe forms or late-stage presentation of corneal decompensation with severe corneal stromal scarring and or scarring to the DM, unsuitable for SNEC-I.
- Patients with complex anterior segment complications precluding a successful SNEC-I procedure
- Patients who have other forms of endothelial dystrophy, traumatic corneal decompensation, or post-inflammatory corneal decompensation
- Post-laser iridotomy or glaucoma related corneal decompensation
- Patients not keen to participate in the clinical trial
- Patients who are below 21 years of age or above 80 years of age
Show all 10Show fewer
- Patients who are pregnant
- Patients who are cognitively impaired
- Patients who are prisoners
- Patients with antibiotics/antimycotics allergies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
India1 site, 1 recruiting
- Recruiting
L V Prasad Eye Institute
Hyderabad, Telangana, 500034
Sunita Chaurasia, 9396475020, sunita@lvpei.org
Sunita Chaurasia
About this study
Official title: Safety and Efficacy of Simple Non-cultured Endothelial Cell Injection(SNEC-I) Therapy for Corneal Endothelial Dysfunction
Assessment of safety and efficacy of cell injection therapy generated using non-cultured human corneal endothelial cells in treating corneal endothelial dysfunction
Read the detailed description
The specific aim of this clinical trial is to assess the clinical efficacy and safety outcomes of patients receiving cell injection therapy generated from non-cultured human corneal endothelial cells. Clinical assessments include postoperative visual acuity, intraocular pressure, keratometric astigmatism, spherical equivalent, endothelial cell density, anterior segment optical coherence tomography (ASOCT), contrast sensitivity, as well as any postoperative complications such as graft dislocation or primary graft failure.
- Conditions
- Bullous Keratopathy, Corneal Endothelial Dystrophy
- Being tested
- Cell injection
- Keywords
- Cell therapy, Corneal endothelial dystophy, corneal endothelial dysfunction, cell injection
- Medical subject headings
- Corneal Dystrophy, Posterior Polymorphous, 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell injectionBiological
Direct endothelial cell injection of non-cultured corneal endothelial cells
| Study group | Role | What they receive |
|---|---|---|
| Cell Injection | Experimental | Direct endothelial cell injection Receives: Biological: Cell injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
BSCVA
Snellen best spectacle-corrected visual acuity (BSCVA). The Snellen BSCVA will be converted to logarithm of the minimum angle of resolution visual acuity for statistical analysis.
Measured: 1, 3, 6, 12 months post-operatively
Secondary outcomes (5)
Autokeratorefractometer
Keratometric astigmatism and spherical equivalent: will be measured by an autokeratorefractometer (RK-8100; Topcon, Tokyo, Japan)
Measured: 1, 3, 6, and 12 months post-operatively
Intraocular pressure
Intraocular pressure: will be measured by a noncontact tonometry (CT-60; Topcon)
Measured: 1, 3, 6 and 12 months post-operatively
Endothelial Cell Density
Endothelial cell density (ECD): will be measured by a noncontact specular microscope (Konan Medical Corp, Hyogo, Japan). The ECD data will be expressed as percentage of cell loss compared with the donor ECD
Measured: 1, 3, 6 and 12 months post-operatively
Graft thickness
Graft thickness: will be measured by ASOCT (Visante OCT, Carl Zeiss Meditec)
Measured: 1, 3, 6 and 12 months post-operatively
Contrast Sensitivity
Measured: 6, 12 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start22 Jun 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bullous KeratopathyStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore Eye Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- L.V. Prasad Eye Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711561
- Sponsor's protocol ID
- 2024/2127
- Other IDs
- CTRI/2026/06/111973
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Simple Non-cultured Endothelial Cell Injection(SNEC-I) Therapy for Corneal Endothelial Dysfunction
- ClinicalTrials.gov ID
- NCT07711561
- Acronym / sponsor ID
- 2024/2127
- Conditions
- Bullous Keratopathy, Corneal Endothelial Dystrophy
- Keywords
- Cell therapy, Corneal endothelial dystophy, corneal endothelial dysfunction, cell injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Singapore Eye Research InstituteUniversity, hospital or other
- Collaborators
- L.V. Prasad Eye Institute
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 17 Jul 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.
Assessment of safety and efficacy of cell injection therapy generated using non-cultured human corneal endothelial cells in treating corneal endothelial dysfunction
Detailed description
The specific aim of this clinical trial is to assess the clinical efficacy and safety outcomes of patients receiving cell injection therapy generated from non-cultured human corneal endothelial cells. Clinical assessments include postoperative visual acuity, intraocular pressure, keratometric astigmatism, spherical equivalent, endothelial cell density, anterior segment optical coherence tomography (ASOCT), contrast sensitivity, as well as any postoperative complications such as graft dislocation or primary graft failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cell Injection | Experimental | Biological: Cell injectionDirect endothelial cell injection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who have mild to moderate corneal endothelial decompensation or bullous keratopathy, but with minimal corneal stromal scarring resulting from irreversible post-surgical corneal decompensation, specifically, all forms of pseudophakic or aphakic bullous keratopathy.
Key exclusion criteria (10 listed)
- Severe forms or late-stage presentation of corneal decompensation with severe corneal stromal scarring and or scarring to the DM, unsuitable for SNEC-I.
- Patients with complex anterior segment complications precluding a successful SNEC-I procedure
- Patients who have other forms of endothelial dystrophy, traumatic corneal decompensation, or post-inflammatory corneal decompensation
- Post-laser iridotomy or glaucoma related corneal decompensation
- Patients not keen to participate in the clinical trial
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 |
|---|---|---|
| Cell injectionDirect endothelial cell injection of non-cultured corneal endothelial cells | Biological | Cell Injection |
Primary outcome
BSCVA
Time frame: 1, 3, 6, 12 months post-operatively
Snellen best spectacle-corrected visual acuity (BSCVA). The Snellen BSCVA will be converted to logarithm of the minimum angle of resolution visual acuity for statistical analysis.
5 secondary outcomes
Autokeratorefractometer
Time frame: 1, 3, 6, and 12 months post-operatively
Intraocular pressure
Time frame: 1, 3, 6 and 12 months post-operatively
Endothelial Cell Density
Time frame: 1, 3, 6 and 12 months post-operatively
Graft thickness
Time frame: 1, 3, 6 and 12 months post-operatively
Contrast Sensitivity
Time frame: 6, 12 months post-operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cell injection in people with Bullous Keratopathy and Corneal Endothelial Dystrophy, run by Singapore Eye Research Institute at 1 site in India.
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 1 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 17 Jul 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 India. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BSCVA (time frame: 1, 3, 6, 12 months post-operatively). 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 17 Jul 2026.