| CTRI Number |
CTRI/2024/07/071429 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema. (DIAMOND-2)
|
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Scientific Title of Study
|
A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in Subjects with Diabetic Macular Edema. |
| Trial Acronym |
(DIAMOND-2) |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DX221 Version 2.0, Dated: 10 Jan 2024 |
Protocol Number |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Aparna Parikh |
| Designation |
Executive Director & Country Consultant for India |
| Affiliation |
Pharmaceutical Research Associates India Private Limited |
| Address |
Pharmaceutical Research Associates India Private Limited
Regus Kaledonia, Unit No 1B, Office No 538, 05th Floor, Sahar Road, Off Western Express Highway, Andheri East
Mumbai
MAHARASHTRA
400069
India |
| Phone |
914497032707 |
| Fax |
912266089696 |
| Email |
Aparna.Parikh@iconplc.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aparna Parikh |
| Designation |
Executive Director & Country Consultant for India |
| Affiliation |
Pharmaceutical Research Associates India Private Limited |
| Address |
Pharmaceutical Research Associates India Private Limited
Regus Kaledonia, Unit No 1B, Office No 538, 05th Floor, Sahar Road, Off Western Express Highway, Andheri East
Mumbai
MAHARASHTRA
400069
India |
| Phone |
914497032707 |
| Fax |
912266089696 |
| Email |
Aparna.Parikh@iconplc.com |
|
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Source of Monetary or Material Support
|
| Oculis Operations SÃ rl, EPFL Innovation Park Building D 1015 Lausanne Switzerland. |
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Primary Sponsor
|
| Name |
Oculis Operations SÃ rl |
| Address |
EPFL Innovation Park Building D 1015 Lausanne Switzerland. |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
|
| Name |
Address |
| Pharmaceutical Research Associates India Private Limited |
Regus Kaledonia, Unit No 1B, Office No 538, 05th Floor, Sahar Road, Off Western Express Highway, Andheri East, Mumbai – 400069 Maharashtra India. |
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Countries of Recruitment
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United States of America
Argentina
Bulgaria
Canada
Czech Republic
France
Germany
India
Italy
Spain
Republic of Korea |
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Sites of Study
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| No of Sites = 7 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vishal Agrawal |
Agrawal Hospital |
Room No. 08, Ground Floor, Ophthalmology division, SP-3 Malviya Industrial Area, Malviya Nagar, Jaipur-302017 Rajasthan India.
Jaipur
RAJASTHAN |
9024472330
drvishalsms@gmail.com |
| Dr Atanu Biswas |
College of Medicine and JNM Hospital |
Room number -100, OPD Building – ground Floor, ophthalmology department, Block-A, Kalyani, Nadia, West Bengal- 741235, India.
Nadia
WEST BENGAL |
7980529743
dratanubiswas@gmail.com |
| Dr Perwez Khan |
G.S.V.M Medical College |
Room no. 01, Ground Floor, Department of Opthalmology, Swaroop Nagar, Kanpur- 208002, Uttar Pradesh, India.
Kanpur Nagar
UTTAR PRADESH |
9451875355
drperwezkhan.research@gmail.com |
| Dr Ashish Sharma |
Lotus Eye Hospital and Institute |
Room No. F06, Avinashi Road, near passport office, Peelamedu, Civil aerodrome post Coimbatore 641014, India.
Coimbatore
TAMIL NADU |
8144973937
drashish79@hotmail.com |
| Dr Santosh Gopi Krishna G |
Narayana Nethralaya |
Room No: 04,Vitreoretina Department, B Block, Basement, 121/C, Chord Road, Near Iskcon Temple, 1st R Block, Rajajinagar, Bangalore, Karnataka -560010, India.
Bangalore
KARNATAKA |
9880643039
drsantoshgk@gmail.com |
| Dr Rohan Chauhan |
Rising Retina Clinic |
312-313, Iscon Centre, Shivranjani Cross Roads, Satellite, Ahmadabad-380015, Gujarat, India.
Ahmadabad
GUJARAT |
9825203022
rohan_28782@yahoo.co.in |
| Dr Mahajan Sheshadri Vishnu |
St. Theresas Hospital |
Ophthalmology Department, OP Room Number: 01, Sanathnagar, Hyderabad, Telangana-500018,India.
Hyderabad
TELANGANA |
8686494949
drsheshadri@gmail.com |
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Details of Ethics Committee
|
| No of Ethics Committees= 7 |
| Name of Committee |
Approval Status |
| Ethics Committee G.S.V.M Medical College Kanpur, Uttar Pradesh |
Approved |
| Ethics Committee, St. Theresas Hospital, Sanathnagar, Hyderabad, Telangana |
Approved |
| I.E.C College of Medicine and JNM Hospital, Kalyani, Nadia, West Bengal |
Submittted/Under Review |
| Institutional Human Ethics Committee, PSG Institute of Medical Sciences and Research, Coimbatore, Tamil Nadu |
Submittted/Under Review |
| Medilink Ethics Committee, Ahmedabad, Gujarat |
Approved |
| Narayana Nethralaya Ethics Committee, Rajajinagar, Bangalore, Karnataka |
Submittted/Under Review |
| Somani Hospital Ethics Committee, Jaipur, Rajasthan |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexamethasone ophthalmic suspension (OCS-01) |
The interventional drug OCS-01 eye drops will be dispensed in single dose containers for each subject to have enough medication until the next visit. Subjects will be dosed with eye drop of OCS-01 6 times per day for 6 weeks (induction phase) followed by 3 times per day for 46 weeks (maintenance phase) |
| Comparator Agent |
Vehicle/Placebo |
The vehicle drug (placebo) eye drops will be dispensed in single dose containers for each subject to have enough medication until the next visit. Subjects will be dosed with eye drop of vehicle 6 times per day for 6 weeks (induction phase) followed by 3 times per day for 46 weeks (maintenance phase)
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Have a signed informed consent form before any study-specific procedures are performed.
2. Have DME with presence of intraretinal and/or subretinal fluid in the study eye, with CST of ≥310 µm by SD-OCT at screening (Visit 1) (as assessed by an independent reading center).
3. Have a documented diagnosis of Type 1 or Type 2 diabetes mellitus and an HbA1c of ≤ 10.0% prior to screening (Visit 1).
|
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| ExclusionCriteria |
| Details |
1. Have macular edema considered to be because of a cause other than DME.
2. Have a decrease in BCVA because of causes other than DME.
3. Have a known history of significant macular ischemia which would prevent gain in visual acuity in the study eye.
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
|
Centralized |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Mean change from baseline in BCVA (Best Corrected Visual Acuity)- Assessed using ETDRS (Early Treatment Diabetes Retinopathy Study) letters score: higher numbers on the EDTRS chart representing better visual acuity |
Week 52 |
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Secondary Outcome
|
| Outcome |
TimePoints |
| Proportion of subjects with 3-line or greater gain in BCVA ETDRS letters compared with baseline |
Week 52 |
|
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Target Sample Size
|
Total Sample Size="350"
Sample Size from India="32"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
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Date of First Enrollment (India)
|
12/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
15/03/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
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Years="1"
Months="1"
Days="4" |
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Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
N/A |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
This is randomized, placebo controlled, parallel-group, phase 3 study to enroll approx. 32 subjects from India [Male or Female of 18 to 85 years of age with type 1 or 2 diabetes mellitus and diabetic macular edema (DME)]. The objective of this study is to demonstrate efficacy and safety of OCS-01 as compared to vehicle/placebo at Week 52. OCS-01 is a novel topical eye drop formulation with a different route of administration from the currently available therapies. |