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CTRI Number  CTRI/2024/07/070816 [Registered on: 18/07/2024] Trial Registered Prospectively
Last Modified On: 12/07/2024
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-1).  
Scientific Title of Study   A phase 2/3 double-masked, randomized, 2 stage, multicenter study of the efficacy and safety of OCS-01 eye drops in subjects with diabetic macular edema. 
Trial Acronym  (Diamond-1) 
Secondary IDs if Any  
Secondary ID  Identifier 
DX219 Version 5.0, Dated: 10 Jan 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
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  Regus Kaledonia, Unit No 1B, Office No 538, 05th Floor, Sahar Road, Off Western Express Highway, Andheri (east)

Mumbai (Suburban)
MAHARASHTRA
400069
India 
Phone  914497032707  
Fax    
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  Regus Kaledonia, Unit No 1B, Office No 538, 05th Floor, Sahar Road, Off Western Express Highway, Andheri (east)


MAHARASHTRA
400069
India 
Phone  914497032707  
Fax    
Email  Aparna.Parikh@iconplc.com  
 
Source of Monetary or Material Support  
Oculis Operations Sàrl, EPFL Innovation Park Building D 1015 Lausanne Switzerland  
 
Primary Sponsor  
Name  Oculis Operations Sàrl 
Address  EPFL Innovation Park Building D 1015 Lausanne, Switzerland. 
Type of Sponsor  Pharmaceutical industry-Global 
 
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 
 
Countries of Recruitment     Germany
Hong Kong
Hungary
India
Israel
Poland
Spain
Taiwan
United States of America  
Sites of Study  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Gopal S Pillai  Amrita Institute of Medical Sciences & Research Centre  Department of Ophthalmology, AIMS Ponekkara P.O, Kochi- 682041, Kerala.
Ernakulam
KERALA 		 919447391266

gopal@ioctn.org 
Dr Jigneshgiri Gonsai  Government Eye Hospital, M & J Institute Of Ophthalmology  Room No. 253, Clinical Research Room, Director Office, Manjushri Mill Compound, Asarwa, Ahmedabad – 380016.
Ahmadabad
GUJARAT 		 919824321195

dr_jigneshgosai@hotmail.com 
Dr Shahana Mazumdar  ICARE Eye Hospital & Post Graduate Institute  Retina Department, Room no. 10, E-3A Sector-26, Noida, Uttar Pradesh- 201301
Gautam Buddha Nagar
UTTAR PRADESH 		 919818575883

shahana.mazumdar@gmail.com 
Dr Umesh Behera  L V Prasad Eye Institute   Retina & Vitreous Services, MTC Campus, Patia, Bhubaneswar-751024, Orissa
Khordha
ORISSA 		 919853011697

umesh@lvpei.org 
Dr Sribhargava Natesh  Nethra Eye Hospital  Consultation-4, 2nd Floor, Retina Department, No. 08, Poojary Layout, 80 Ft Road, Sanjaynagar, RMV 2nd stage, Bangalore – 560094
Bangalore
KARNATAKA 		 919342880273

sribhargava.natesh@gmail.com 
Dr Shilpi Narnaware  Sarakshi Netralaya  Plot No. 19, Pragati Co-operative Housing Society, Rajiv Nagar, Wardha road, Nagpur – 440025.
Nagpur
MAHARASHTRA 		 919923522016

shilpi.narnaware@gmail.com 
Dr Shobhana Mange  Shivam Retina Clinic and Eye Hospital  HG-1 A, ITC Building, Majura Gate, Ring Road, Surat-395001
Surat
GUJARAT 		 912614894414

drshobhanamange@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
ICARE Eye Hospital and PGI Ethics Committee, ICARE Eye Hospital and Postgraduate Institute  Submittted/Under Review 
Institutional Ethics Committee, Amrita Institute of Medical Sciences  Submittted/Under Review 
Institutional Ethics Committee, B.J. Medical College and Civil Hospital  Submittted/Under Review 
Institutional Ethics Committee, L V Prasad Eye Institute  Approved 
Pranav Diabetes Center Ethics Committee, Pranav Diabetes Center  Approved 
SKCC Institutional Ethics Committee, SS Multispecialty Hospital  Submittted/Under Review 
Unity Hospital Ethics Committee, Unity Trauma Center and ICU  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E113||Type 2 diabetes mellitus with ophthalmic complications,  
 
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 weeks (maintenance phase).  
 
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).
 
 
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.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant and Investigator Blinded 
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 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of subjects with 3-line or greater gain in BCVA ETDRS letters compared with baseline.   Week 52 
 
Target Sample Size   Total Sample Size="350"
Sample Size from India="30" 
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 2/ Phase 3 
Date of First Enrollment (India)   30/07/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/01/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="11"
Days="29" 
Recruitment Status of Trial (Global)   Open to Recruitment 
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 randomized, placebo controlled, parallel-group, phase 2/3 study to enroll approx. 30 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. 
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