Retinal DiseasePhase 1/2NCT06394232
Safety & Efficacy of Eyecyte-RPE™ in Patients With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration.
A Phase 1/2 study testing Eyecyte-RPE™ in people with Retinal Disease and Macular Degeneration, run by Eyestem Research Pvt. Ltd. at 3 sites in India.
Trial summary
The goal of this clinical study is to evaluate the safety and efficacy of novel stem cell formulation in patients having Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (d-AMD). Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Retinal Disease, Macular Degeneration, Age-Related Macular Degeneration
- What is being tested?
- Eyecyte-RPE™
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 3 sitesIndia
- Study dates
- 4 Jun 2024to Dec 2030
- Phase
- Phase 1/2
- 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 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women ≥ 50 years of age at Screening.
- Diagnosis of Geographic Atrophy secondary to d-AMD
- Have Best Corrected Visual Acuity (BCVA) equal to or less than 20/200 Snellen (ETDRS letter score ≤ 35) in the study eye at screening.
- Phase 1 ≤ 20/200 and
- Phase 2a ≥ 20/64 (ETDRS letter score 60) in the study eye at Screening.
- Vision in the unoperated eye must be better or equal to vision in the study eye.
Show all 16Show fewer
- Willing, committed, and able to return for ALL clinic visits and complete all study related procedures.
- Be medically suitable to undergo anesthesia, vitrectomy and subretinal injection in the opinion of the Investigator.
- Be medically suitable for immunosuppression therapy in accordance with the requirements of this protocol in the opinion of the Investigator.
- Able to read (or if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) and understand, and willing to sign the informed consent form (ICF)
- Willing to provide signed Informed Consent prior to any procedures being performed at Visit 1, Screening.
- Negative for HIV, HbsAg, HCV, TB
- The GA lesion must meet the following criteria as determined by the central reading center's assessment of Fundus Autofluorescence (FAF) imaging at screening:
- Total GA area must be ≥ 1.25 and ≤ 17.5 mm2 (0.5 and 7 disk areas [DA] respectively)
- The entire GA lesion must be completely visualized on the macula centered image and must be able to be imaged in its entirety and not contiguous with any areas of peripapillary atrophy.
- At least one of the lesions has to be sub-foveal.
Who cannot join
- Have evidence of neovascular AMD in either eye by clinical examination, fluorescein angiography or optical coherence tomography.
- Have GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like Chloroquine maculopathy in either eye.
- Have any evidence of active or inactive choroidal neovascularization (CNV) due to other causes such as ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, uveitis, punctate inner choroidopathy, or multifocal choroiditis in the study eye.
- Axial myopia greater than -6 diopters or axial length more than 26 mm.
- Have a decrease in BCVA in the study eye due to causes other than GA (e.g., pigment abnormalities, dense sub foveal hard exudates, previous vitreoretinal surgery, retinal dystrophies, non-retinal conditions, visually significant cataract, macular ischemia, etc.).
- Have the presence of retinal pigment epithelial tears or rips involving the macula in the study eye at screening.
Show all 28Show fewer
- Have a history or evidence of vitreous hemorrhage in the study eye.
- Have a history or clinical evidence of severe diabetic retinopathy, diabetic macular edema, retinal vein occlusion or any other vascular disease affecting the retina in the study eye.
- Have had a prior pars plana vitrectomy in the study eye.
- Have a history of retinal detachment or treatment or surgery for retinal detachment in the study eye.
- Have history of a macular hole in the study eye.
- Have had any other ocular surgery (except cataract) within 2 months or Yttrium Aluminum Garnet (YAG) laser capsulotomy in the study eye in the past 4 weeks.
- Have had a prior trabeculectomy or other filtration surgery in the study eye.
- History of any form of glaucoma in the study eye.
- Patients with ocular pathology, particularly that of retina (other than AMD).
- Have active intraocular inflammation or a history or evidence of uveitis in either eye.
- Have active ocular or periocular infection in either eye, or a history of any ocular or periocular infection within the 2 weeks prior to Visit 1, Screening in either eye.
- Have a history of scleromalacia in either eye.
- Have had previous therapeutic radiation in the study eye.
- Have a history of corneal transplant or corneal dystrophy.
- Have any concurrent ocular condition in the study eye which, in the opinion of the investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of intraocular injection, or which otherwise may interfere with the injection procedure or with evaluation of efficacy or safety.
- Have a history of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk for treatment complications.
- Have participated as a subject in any clinical study within 6 months prior to Day 0, Baseline.
- Have a known serious allergy to fluorescein sodium for injection in angiography, Povidone Iodine or any of the other medications required for anesthesia or the subretinal injection procedure.
- Be a female who is pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study at Screening and Baseline.
- Currently receiving aspirin, aspirin containing products and/or any other coagulation modifying drugs which cannot be discontinued 7 days prior to surgery.
- Have any systemic condition that would qualify the subject as being immunocompromised (e.g., severely uncontrolled diabetes, cancer).
- Patients with Optic Atrophy
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
India3 sites, 3 recruiting
- Recruiting
All India Institute of Medical Sciences
Delhi, New Delhi, 110029
Dr.Rajpal, MBBS,MD
- Recruiting
L V Prasad Eye Institute
Hyderabad, Telangana, 500034
Dr.Raja Narayanan, MBBS,MS
- Recruiting
Shri Ganapati Netralaya
Jālna, Maharashtra, 431203
Dr.Rushikesh Arunrao, MBBS,DNB
About this study
Official title: A Phase 1/2a Multi-Center, Dose-Escalation Study to Evaluate the Safety & Efficacy of Eyecyte-RPE™ When Administered as a Single-dose Subretinal Injection in Subjects With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration
The goal of this clinical study is to evaluate the safety and efficacy of novel stem cell formulation in patients having Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (d-AMD).
The main questions it aims to answer are:
- Safety and tolerability of the novel stem cell formulation
- Potential efficacy of the novel stem cell formulation
Participants will receive a single subretinal injection in their study eye and followed up for safety.
This is an India only study and the product is developed indigenously.
Read the detailed description
Age-related Macular Degeneration (AMD) is a leading cause of vision impairment in the elderly and substantially affects the quality of life of an individual. Although the exact pathophysiological mechanisms behind the disease are multifactorial and complex, several genetic and environmental risk factors are associated with AMD, such as age, cigarette smoking, hypertension, abdominal obesity, dietary fat, and low physical activity.
Geographic Atrophy (GA) is the late stage of dry AMD(d-AMD). GA is a slow but inexorably progressive disease that causes irreversible blindness over time. Several new non-invasive tools such as Fundus Autofluorescence (FAF), Optical Coherence Tomography (OCT), and OCT Angiography (OCT-A) are being used to enable early diagnosis and follow up in these patients. Despite these advances, there are currently no approved treatments for GA that can replace the damaged RPE, photoreceptors, or outer retinal layers. In recent years, stem cell replacement therapy is being evaluated as an alternative to treat d-AMD.
In the pursuit to find a promising solution for d-AMD, which is an unmet medical need globally, Eyestem has been striving to develop a safe and effective stem-cell based therapy.
Theoretically, human induced pluripotent stem cells(hiPSCs) derived Eyecyte-RPE™, developed by Eyestem can help replace the damaged or lost retinal pigment epithelial (RPE) cells and potentially enable tissue regeneration in the diseased retina. In addition, stem cells can perform multiple functions, such as immunoregulation, prevention of apoptosis in sensory neurons, and secretion of neurotrophic factors. The latest stem cell transplantation studies performed by other research groups has been able to demonstrate that this therapy has a promising approach to restore visual function in eyes with degenerative retinal diseases.
The results of the pre-clinical safety and efficacy studies with Eyecyte-RPE™ have been very encouraging. It has been shown to provide significant beneficial effects on the degenerating retina in animals without any significant safety concerns, suggesting that this therapy may have substantial therapeutic value in d-AMD.
- Conditions
- Retinal Disease, Macular Degeneration, Age-Related Macular Degeneration, Geographic Atrophy, Eye Diseases
- Being tested
- Eyecyte-RPE™
- Keywords
- Age Related Macular Degeneration, Geographic Atrophy, Visual Impairment, Subretinal injection, Stem cells, Retinal Pigment Epithelial Cells
- Medical subject headings
- Retinal Diseases, Macular Degeneration, Geographic Atrophy, Eye Diseases, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eyecyte-RPE™Drug
Also called Subretinal Injection, Oral Tacrolimus, Oral Mycophenolate Sodium
Eyecyte-RPE™ is a suspension of hiPSCs (human induced Pluripotent Stem Cells) derived Retinal Pigment Epithelial Cells
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1-Cohort 1 | Experimental | Subjects who are allocated to Dose Level 1-Cohort 1 will receive 100,000 cells of Eyecyte-RPE™ Receives: Drug: Eyecyte-RPE™ |
| Dose Level 2-Cohort 2 | Experimental | Subjects who are allocated to Dose Level 2-Cohort 2 will receive 200,000 cells of Eyecyte-RPE™ Receives: Drug: Eyecyte-RPE™ |
| Dose Level 3-Cohort 3 | Experimental | Subjects who are allocated to Dose Level 3-Cohort 3 will receive 300,000 cells of Eyecyte-RPE™ Receives: Drug: Eyecyte-RPE™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fundus Autofluorescence-
Overall change in the geographic atrophy (GA) lesion area of the study eye over time using Fundus Autofluorescence (FAF)
Measured: Upto 12 months
Secondary outcomes (5)
Best Corrected Visual Acuity (BCVA)-Mean change from baseline in BCVA score in study eye and fellow eye.
Change from baseline over time in BCVA as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) chart. The BCVA score (in letter units) will be reported.
Measured: Upto 12 months
Spectral-Domain Optical Coherence Tomography (SD-OCT)-Mean change from baseline in the Geographic Atrophy (GA) area in study eye and fellow eye
Overall change in the GA lesion area of the study eye over time using SD-OCT
Measured: Upto 12 months
Fundus Photography- Changes between study eye and fellow eye
Correlation assessment between quantitative metrics derived from Color fundus photography images
Measured: Upto 12 months
Microperimetry-Mean change from baseline in mean sensitivity
Change from initial assessment over time in retinal sensitivity, as assessed by Microperimetry (MP)
Measured: Upto 12 months
National Eye Institute-Visual Function Questionnaire Quality of Life score
Change over time in National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) Quality of Life (QoL) score
Measured: Upto 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start4 Jun 2024
- Primary completionApr 2025 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Retinal DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Subjects will be enrolled into 3 sequential, ascending dose-level (DL) cohorts to enroll a maximum of 18 subjects. There will be three Cohorts 1. DL1-Cohort 1: Eyecyte-RPE™ 100,000 cells 2. DL2-Cohort 2: Eyecyte-RPE™ 200,000 cells 3. DL3-Cohort 3: Eyecyte-RPE™ 300,000 cells
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eyestem Research Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394232
- Sponsor's protocol ID
- ERPL-CTP-001
- Status last verified
- Sep 2024
- First submitted
- 15 Apr 2024
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Soundararajan L, Surendran H, Patlolla N, Battu R, Stoddard J, Arrizabalaga S, Liu Z, Lingam G, Su X, Ryals RC, Pal R. Allogeneic RPE cell suspension manufactured at scale demonstrating preclinical safety and efficacy led to IND approval. NPJ Regen Med. 2025 Apr 19;10(1):19. doi: 10.1038/s41536-025-00407-0.
PubMed 40253438
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2a Multi-Center, Dose-Escalation Study to Evaluate the Safety & Efficacy of Eyecyte-RPE™ When Administered as a Single-dose Subretinal Injection in Subjects With Geographic Atrophy Secondary to Dry Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT06394232
- Acronym / sponsor ID
- ERPL-CTP-001
- Conditions
- Retinal Disease, Macular Degeneration, Age-Related Macular Degeneration, Geographic Atrophy, Eye Diseases
- Keywords
- Age Related Macular Degeneration, Geographic Atrophy, Visual Impairment, Subretinal injection, Stem cells, Retinal Pigment Epithelial Cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Eyestem Research Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Jun 2024 (actual)
- Primary completion
- Apr 2025 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 1 May 2024 (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 clinical study is to evaluate the safety and efficacy of novel stem cell formulation in patients having Geographic Atrophy (GA) Secondary to Dry Age-related Macular Degeneration (d-AMD).
The main questions it aims to answer are:
- Safety and tolerability of the novel stem cell formulation
- Potential efficacy of the novel stem cell formulation
Participants will receive a single subretinal injection in their study eye and followed up for safety.
This is an India only study and the product is developed indigenously.
Detailed description
Age-related Macular Degeneration (AMD) is a leading cause of vision impairment in the elderly and substantially affects the quality of life of an individual. Although the exact pathophysiological mechanisms behind the disease are multifactorial and complex, several genetic and environmental risk factors are associated with AMD, such as age, cigarette smoking, hypertension, abdominal obesity, dietary fat, and low physical activity.
Geographic Atrophy (GA) is the late stage of dry AMD(d-AMD). GA is a slow but inexorably progressive disease that causes irreversible blindness over time. Several new non-invasive tools such as Fundus Autofluorescence (FAF), Optical Coherence Tomography (OCT), and OCT Angiography (OCT-A) are being used to enable early diagnosis and follow up in these patients. Despite these advances, there are currently no approved treatments for GA that can replace the damaged RPE, photoreceptors, or outer retinal layers. In recent years, stem cell replacement therapy is being evaluated as an alternative to treat d-AMD.
In the pursuit to find a promising solution for d-AMD, which is an unmet medical need globally, Eyestem has been striving to develop a safe and effective stem-cell based therapy.
Theoretically, human induced pluripotent stem cells(hiPSCs) derived Eyecyte-RPE™, developed by Eyestem can help replace the damaged or lost retinal pigment epithelial (RPE) cells and potentially enable tissue regeneration in the diseased retina. In addition, stem cells can perform multiple functions, such as immunoregulation, prevention of apoptosis in sensory neurons, and secretion of neurotrophic factors. The latest stem cell transplantation studies performed by other research groups has been able to demonstrate that this therapy has a promising approach to restore visual function in eyes with degenerative retinal diseases.
The results of the pre-clinical safety and efficacy studies with Eyecyte-RPE™ have been very encouraging. It has been shown to provide significant beneficial effects on the degenerating retina in animals without any significant safety concerns, suggesting that this therapy may have substantial therapeutic value in d-AMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Subjects will be enrolled into 3 sequential, ascending dose-level (DL) cohorts to enroll a maximum of 18 subjects. There will be three Cohorts 1. DL1-Cohort 1: Eyecyte-RPE™ 100,000 cells 2. DL2-Cohort 2: Eyecyte-RPE™ 200,000 cells 3. DL3-Cohort 3: Eyecyte-RPE™ 300,000 cells
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1-Cohort 1 | Experimental | Drug: Eyecyte-RPE™Subjects who are allocated to Dose Level 1-Cohort 1 will receive 100,000 cells of Eyecyte-RPE™ |
| Dose Level 2-Cohort 2 | Experimental | Drug: Eyecyte-RPE™Subjects who are allocated to Dose Level 2-Cohort 2 will receive 200,000 cells of Eyecyte-RPE™ |
| Dose Level 3-Cohort 3 | Experimental | Drug: Eyecyte-RPE™Subjects who are allocated to Dose Level 3-Cohort 3 will receive 300,000 cells of Eyecyte-RPE™ |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Men and women ≥ 50 years of age at Screening.
- Diagnosis of Geographic Atrophy secondary to d-AMD
- Have Best Corrected Visual Acuity (BCVA) equal to or less than 20/200 Snellen (ETDRS letter score ≤ 35) in the study eye at screening.
- Vision in the unoperated eye must be better or equal to vision in the study eye.
- Willing, committed, and able to return for ALL clinic visits and complete all study related procedures.
Key exclusion criteria (28 listed)
- Have evidence of neovascular AMD in either eye by clinical examination, fluorescein angiography or optical coherence tomography.
- Have GA secondary to a condition other than AMD such as Stargardt disease, cone rod dystrophy or toxic maculopathies like Chloroquine maculopathy in either eye.
- Have any evidence of active or inactive choroidal neovascularization (CNV) due to other causes such as ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, uveitis, punctate inner choroidopathy, or multifocal choroiditis in the study eye.
- Axial myopia greater than -6 diopters or axial length more than 26 mm.
- Have a decrease in BCVA in the study eye due to causes other than GA (e.g., pigment abnormalities, dense sub foveal hard exudates, previous vitreoretinal surgery, retinal dystrophies, non-retinal conditions, visually significant cataract, macular ischemia, etc.).
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 |
|---|---|---|
| Eyecyte-RPE™Also: Subretinal Injection, Oral Tacrolimus, Oral Mycophenolate SodiumEyecyte-RPE™ is a suspension of hiPSCs (human induced Pluripotent Stem Cells) derived Retinal Pigment Epithelial Cells | Drug | Dose Level 1-Cohort 1, Dose Level 2-Cohort 2, Dose Level 3-Cohort 3 |
Primary outcome
Fundus Autofluorescence-
Time frame: Upto 12 months
Overall change in the geographic atrophy (GA) lesion area of the study eye over time using Fundus Autofluorescence (FAF)
5 secondary outcomes
Best Corrected Visual Acuity (BCVA)-Mean change from baseline in BCVA score in study eye and fellow eye.
Time frame: Upto 12 months
Spectral-Domain Optical Coherence Tomography (SD-OCT)-Mean change from baseline in the Geographic Atrophy (GA) area in study eye and fellow eye
Time frame: Upto 12 months
Fundus Photography- Changes between study eye and fellow eye
Time frame: Upto 12 months
Microperimetry-Mean change from baseline in mean sensitivity
Time frame: Upto 12 months
National Eye Institute-Visual Function Questionnaire Quality of Life score
Time frame: Upto 12 months
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 24 Sep 2024.
- Derived from this study: PubMed 40253438Soundararajan L, Surendran H, Patlolla N, Battu R, Stoddard J, Arrizabalaga S, Liu Z, Lingam G, Su X, Ryals RC, Pal R. Allogeneic RPE cell suspension manufactured at scale demonstrating preclinical safety and efficacy led to IND approval. NPJ Regen Med. 2025 Apr 19;10(1):19. doi: 10.1038/s41536-025-00407-0.
- Individual participant dataSharing planned: No
Related trials for Retinal Disease
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
RecruitingObservational study
Pivotal Trial of an Automated AI-based System for Early Diagnosis and Prediction of Late Age-related Macular Degeneration
Age-related Macular Degeneration (AMD)
Active, not recruitingObservational study
Real World Evidence in China: Faricimab Use in Diabetic Macular Edema, Retinal Vein Occlusion, and Neovascular Age-Related Macular Degeneration (The Farseeing Study)
Diabetic Macular Edema, Neovascular Age-related Macular Degeneration
Active, not recruitingObservational study
Retinal Pigment Epithelium Safety Study For Patients In B4711001
Age Related Macular Degeneration
Not yet recruitingObservational study
Efficacy of Aflibercept (8 mg) With Sequential Laser Photocoagulation for Macular Edema Secondary to Retinal Artery Macroaneurysm: Retrospective Study"
Retinal Arterial Macroaneurysm
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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Eyecyte-RPE™ in people with Retinal Disease and Macular Degeneration, run by Eyestem Research Pvt. Ltd. at 3 sites 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 16 inclusion and 28 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 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Contact Dr Jogin Desai, MBBS (+91 7676235515, jogin.desai@eyestem.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fundus Autofluorescence- (time frame: Upto 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06394232, which also lists 1 linked publication.
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 24 Sep 2024.