| CTRI Number |
CTRI/2024/01/061410 [Registered on: 12/01/2024] Trial Registered Prospectively |
| Last Modified On: |
11/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study to determine the safety and performance of Everads Injector for Injection of triamcinolone acetonide in suprachoroidal space of eye. |
|
Scientific Title of Study
|
Everads Injector in suprachoroidal administration of an approved TA suspension for the treatment of patients with Diabetic Macular Edema: An open label safety and performance pilot study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CL-00004 rev 02, Version 1.1 dated 07th Sept 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Poornachandra B |
| Designation |
Principal Investigator |
| Affiliation |
Narayana Nethralaya |
| Address |
Narayana Nethralaya, Room No.03, Vitreo Retina Department, B block Basement, 121-c chord Road, 1st ‘R’ Block, Rajaji Nagar, Bangalore- 560010.
Bangalore
KARNATAKA
560010
India |
| Phone |
9049116067 |
| Fax |
|
| Email |
punith.poorna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sornaraja Thasma |
| Designation |
Director of Quality Assurance |
| Affiliation |
ProRelix Services LLP |
| Address |
Prorelix Services LLP 102 A/B, Park Plaza, Main Karve nagar chowk, Karve nagar, Pune, Maharashtra 411052
Pune
MAHARASHTRA
411052
India |
| Phone |
8124806366 |
| Fax |
|
| Email |
s.thasma@prorelixresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Sohal Pendse |
| Designation |
Director of Business Operations |
| Affiliation |
ProRelix Services LLP |
| Address |
Prorelix Services LLP 102 A/B, Park Plaza, Main Karve nagar chowk, Karve nagar, Pune, Maharashtra 411052
Pune
MAHARASHTRA
411052
India |
| Phone |
9890096725 |
| Fax |
|
| Email |
s.pendse@prorelixresearch.com |
|
|
Source of Monetary or Material Support
|
| Everads Therapy Ltd. 31 Habarzel St., Tel Aviv 96710, Israel |
|
|
Primary Sponsor
|
| Name |
Everads Therapy Ltd. |
| Address |
Everads Therapy Ltd. 31 Habarzel St., Tel Aviv 96710, Israel |
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Poornachandra B |
Narayana Nethralaya |
Narayana Nethralaya, Room No.03, Vitreo Retina Department, B block Basement, 121-c chord Road, 1st ‘R’ Block, Rajaji Nagar, Bangalore- 560010.
Bangalore
KARNATAKA |
9049116067
punith.poorna@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana Nethralaya Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E103||Type 1 diabetes mellitus with ophthalmic complications, (2) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Everads Injector |
Everads Injector to administer Triamcinolone Acetonide one time, on Injection Visit (Visit 2, Day 1). The total procedure will take less than 15 minutes. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Males and females more than or equal to 18 years of age with a diagnosis of type 1 or type 2 diabetes mellitus. 2. DME with central involvement at the screening visit, of more than or equal to 320 for males or more than or equal to 305 for females on Spectralis (Heidelberg), or more than or equal to 305 for males or more than or equal to 290 for females with Cirrus (Zeiss) by spectral domain optical coherence tomography (SD-OCT). 3. ETDRS BCVA letter score of less than 6/30 in the study eye for both the cohorts, with second eye BCVA of 6/21 or better in both the cohorts. 4.If both the eyes are eligible, the worse eye should be included in the trial and the other eye should receive standard care. If both eyes are eligible and have identical VA, the right eye needs to be included in the study. The untreated eye should receive the standard care by the PI post study treatment and follow up duration. 5.Have shown no response to three previous IVT treatment with antivascular endothelial growth factor (VEGF) agents. 6.Understands the language of the informed consent; willing and able to provide written informed consent prior to any study procedures; willing to comply with the instructions and attend all scheduled study visits. 7.For women at childbearing age: agreement to remain abstinent or use acceptable contraceptive methods. |
|
| ExclusionCriteria |
| Details |
1.Evidence of macular edema due to any cause other than Diabetic retinopathy in the study eye. 2.Prior treatment with pan retinal photocoagulation or focal laser photocoagulation in the study eye within 90 days of screening visit. 3.Intraocular pressure more than or equal to 21 mmHg or uncontrolled glaucoma (open angle or angle closure) in the study eye. 4.History of any prior ophthalmic surgeries in the study eye within 90 days of the screening visit. 5.Patients for whom enrollment into the study, in the principal investigator’s opinion, would put the eye at undue risk for vision loss. 6.Previous treatment for DME with any intravitreal injection in the study eye in the last 90 days prior to the screening visit. 7.Any previous treatment with Ozurdex® implant in past 6 months. 8.Any previous treatment with Iluvien®. 9.Currently enrolled in an investigational drug or device study or has used an investigational drug or device within 30 days or the Screening visit. 10.Any other pre-existing eye conditions or surgical complications that would interfere with the interpretation of study endpoints. 11.Current iris neovascularization, vitreous hemorrhage, tractional retinal detachment or epiretinal membrane involving the macula in the study eye. 12.Known hypersensitivity to any component of or to used suspension or topical anesthetic. 13.Known allergy to nickel. 14.Uncontrolled blood pressure. 15.Pregnant or lactating women. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
•Frequency of treatment-emergent adverse events & serious adverse events (6 weeks).
Treatment-emergent adverse events are defined as an event that emerges following administration of TA with Everads Injector at Visit 2.
•Frequency of adverse device effects & frequency of serious adverse device effects throughout the study period (6 weeks) Adverse device effects and serious adverse device effects are defined as effects that emerge following the administration of the Everads Injector on Visit 2. |
Day 1 to Day 42 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| •Confirmation of delivery into the suprachoroidal space by EDI-OCT. |
Day 1 |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/01/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Approximately 10 Male or female subjects aged more than or equal to 18 years diagnosed with type 1 or type 2 diabetes mellitus will be taken. It is an open label study, there is no randomization and assignment to cohort is sequential. The investigational product is Everads Injector (for target rapid delivery of therapy via suprachoroidal route. The study includes two cohorts of subjects. The first cohort will include 5 subjects with BCVA worse than 6/30 that will be injected with 100ul (4mg of TA) and the second cohort will include 5 subjects with BCVA worse than 6/30 that will be injected with 150ul (6mg of TA). |