| CTRI Number |
CTRI/2026/01/100616 [Registered on: 08/01/2026] Trial Registered Prospectively |
| Last Modified On: |
01/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A study to check the safety and effectiveness of a collagen eye matrix in people with corneal ulcers |
|
Scientific Title of Study
|
A multi-center, open-label, single-arm study to assess the safety and efficacy of collagen ophthalmic matrix for anterior lamellar keratoplasty. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Protocol No.: CT/24/002, Version No.: 01, Date: 25/07/25 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Siddhartha Patil |
| Designation |
Project Manager |
| Affiliation |
Raptim Research Pvt. Ltd |
| Address |
A-242, T.T.C., Industrial Area, Mahape, MIDC,
Mumbai
MAHARASHTRA
400710
India |
| Phone |
9167079505 |
| Fax |
|
| Email |
siddhartha.patil@raptimresearch.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Siddhartha Patil |
| Designation |
Project Manager |
| Affiliation |
Raptim Research Pvt. Ltd |
| Address |
A-242, T.T.C., Industrial Area, Mahape, MIDC,
Mumbai
MAHARASHTRA
400710
India |
| Phone |
9167079505 |
| Fax |
|
| Email |
siddhartha.patil@raptimresearch.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Siddhartha Patil |
| Designation |
Project Manager |
| Affiliation |
Raptim Research Pvt. Ltd |
| Address |
A-242, T.T.C., Industrial Area, Mahape, MIDC,
Mumbai
MAHARASHTRA
400710
India |
| Phone |
9167079505 |
| Fax |
|
| Email |
siddhartha.patil@raptimresearch.com |
|
|
Source of Monetary or Material Support
|
| ACRO Biomedical Co. Ltd.,3rd Floor, No. 57, Luke 2nd Rd., Lujhu District, Kaohsiung City 82151, Taiwan (R.O.C) |
|
|
Primary Sponsor
|
| Name |
ACRO Biomedical Co Ltd |
| Address |
3rd Floor No 57, Luke 2nd Rd Lujhu District, Kaohsiung City 82151, Taiwan R.O.C |
| Type of Sponsor |
Other [innovative developer and manufacturer of medical-grade biomaterials] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Raptim Research Pvt Ltd |
A-242, T.T.C., Industrial Area, Mahape, MIDC, Navi Mumbai - 400 710, India |
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinayak Damgude |
ASG Eye Hospital, Pvt. Ltd |
Sixth floor, Goodwill
Excellency, Plot no.88, Nearby
Tanishq Jeweller, Vashi, - 400703
Mumbai
MAHARASHTRA |
91-8452020450
vnayak7822@gmail.com |
| Dr Dipali Purohit |
C. H. Nagri Eye Hospital |
Room no. 104, 1st floor, Purhtoom Malvankar Marg, Ellis bridge,
380006
Ahmadabad
GUJARAT |
9825257198
senadip@yahoo.co.in |
| Dr Lional Raj |
Dr Agawals Eye Hospital |
No. 15, South Bypass Road, Vannarpettai, 627003
Tirunelveli
TAMIL NADU |
8754411261
drlionalraj@dragarwal.com |
| Dr Anjali Sapar |
Insights Institute of Opthalmology |
Godawoon Chowk, Spine Road, Bhosari 411026
Pune
MAHARASHTRA |
9545680252
dranjalisapar@gmail.com |
| Dr Bhupesh Bagga |
LV Prasad Eye Institute |
Kallam Anji Reddy Campus, L V Prasad Marg, Road No 2, Banjara Hills, - 500034
Hyderabad
TELANGANA |
9618276424
bhupesh@lvpei.org |
| Dr Sujata Das |
LV Prasad Eye Institute |
L V Prasad Eye Institute
Plot No 347 (P) At-Patia, Po- KIIT Bhubaneswar
751024
Khordha
ORISSA |
9437009411
sujatadas@lvpei.org |
| Dr Nita Shanbhag |
Omkar Eye Care Centre |
Koteshwar Plaza, 3rd Floor, 302/303, Jn of Pt Jawaharlal Nehru Road, Above Gapule Sports, Mulund West, 400080,
Mumbai
MAHARASHTRA |
9322402424
nita.eye@gmail.com |
| Dr Rakhi Kusumesh |
Regional Institute Of Ophthalmology IGIMS |
Indira Gandhi Institute of Medical Sciences, Sheikhpura,800014
Patna
BIHAR |
9199242193
drkrakhi@yahoo.com |
| Dr Rohit Ramgopalji Bang |
Shri Krishna Netralaya |
Ground Floor, Plot No 50, Jalna Road, Mahesh Nagar, Akashvani Chowk, Mondha, 431001
Aurangabad
MAHARASHTRA |
9657655211
rohitbang17@gmail.com |
| Dr Dharmaveer Choudhary |
SMS Medical College, |
Charak Bhavan attached to SMS Medical college and Hospital, JLN Marg,302004
Jaipur
RAJASTHAN |
9252032662
drdschaudhary@gmail.com |
| Dr Nidhi Gadkar |
The Kashyap Memorial Eye Hospital |
Purulia Rd near
Dangratoli Chowk 834001
Ranchi
JHARKHAND |
9428051802
drnidhigadkar@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Dr. Agarwals Eye Hospital Institution Review Board |
Approved |
| Ikon Ethics Committee For Research On Human Subject |
Approved |
| Indira Gandhi Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee (NHLIEC) |
Approved |
| Institutional Ethics Committee LV Prasad Eye Institute |
Approved |
| Kashyap Memorial Eye hospital Ethics Committee |
Approved |
| LV Prasad Eye Institute Ethics Committee |
Approved |
| nstitutional Ethics Committee, Insights Institute of Opthalmology |
Approved |
| The Ethics Committee, S.M.S. Medical College and Attached Hospitals |
Approved |
| Vision Independent Ethics Committee |
Approved |
| Vision Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H160||Corneal ulcer, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ABCcolla® Collagen Ophthalmic Matrix
(Decellularized porcine collagen corneal matrix will be applied during Anterior Lamellar Keratoplasty surgery only) |
Duration: Subjects will be followed up for 24 weeks post-implantation of the investigational device.
Route of Administration: Surgical implantation during anterior lamellar keratoplasty
Dosing: A single application per subject |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Male or female aged 20 to 60 years
Patient who has been diagnosed with corneal ulcer due to bacterial, fungal or parasite infection not responding to medical treatment for one to two weeks for bacterial or fungal keratitis and a minimum of one month for parasitic infection; exposure to chemical burns classified as Grade III or IV; or severe trauma not responding to medical treatment
The corneal ulcer affects corneal stroma depth to more than one third and less than two thirds of the stroma and infiltrate more than three millimeters and less than ten millimeters in diameter, detected by Optical Coherence Tomography
Best Corrected Visual Acuity of less than 0.05 as measured on the logMAR chart, equivalent to Snellen notation 20 over 400 in feet or 6 over 120 in meters
Patient or impartial witness who signs the informed consent form and agrees to complete the treatment and follow-up
Patients who are not responsive to treatment for one to two weeks for bacterial or fungal keratitis and a minimum of one month for parasitic infection |
|
| ExclusionCriteria |
| Details |
Treated with keratoplasty before
Has a corneal ulcer smaller than 3 mm or larger than 10 mm in diameter
Has corneal ulcer infiltrates less than one third or more than two thirds in depth
Has severe dry eye disease as assessed by Schirmers Test II less than 5 mm
Has cataracts on the eyes
Experiences incomplete eyelid closure
Has liver function ALT and AST tests with the score as two fold or greater than that of the normal
Has renal function creatinine Cr level greater than two fold of the normal
Has serum albumin level lower than 10 percent of normal value
Has severe cardiovascular and cerebral vascular disease
Has diabetes
Has a malignant or benign tumor
Known to be allergic to collagen
Has a systemic collagen connective tissue disease
Has allergic reactions to porcine tissue
Use of anticoagulants five days before screening
Use of topical oral or injectable NSAIDs three days before screening
The patient does not accept porcine tissue for any reason
Pregnant or breastfeeding women or childbearing age women who plan to get pregnant
Participates in other drug or medical instrument clinical trials in the last 12 weeks
Not being considered suitable for this study by the principal investigator
Has glaucoma
Cases with defective limbus or cornea without limbus or severe injury to limbus |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of irreversible graft dissociation melting or rejection up to 6 months Adverse events TEAE
|
Up to 6 months 24 weeks post implantation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Graft transparency
Neovascularization
Infection recurrence
Edema
BCVA
Vital signs
Lab tests
Epithelial reconstruction
IOP, graft and bed thickness
|
Up to 6 months 24 weeks post implantation |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/01/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This is a multi-centre, open-label, single-arm
phase III clinical study evaluating the safety, efficacy and acceptability of
ABCcolla® Collagen Ophthalmic Matrix in patients with non-healing corneal
ulcers undergoing lamellar keratoplasty. The study involves 150 patients across
India, with a follow-up of 24 weeks |