| CTRI Number |
CTRI/2026/04/107566 [Registered on: 06/04/2026] Trial Registered Prospectively |
| Last Modified On: |
25/08/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Clinical Study to compare the effect of AVT29 with Eylea High Dose (HD) in patients with Diabetic Macular Edema. |
|
Scientific Title of Study
|
A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared with Eylea High Dose (HD) in Participants with Diabetic Macular Edema (ALVOEYE-HD). |
| Trial Acronym |
Clinical Study to Compare Efficacy and Safety of AVT29 and Eylea HD in
Participants with Diabetic Macular Edema |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2025-522231-34-00 |
EudraCT |
| AVT29-GL-C01 Version 2.0, Amendment 1.0 dated 17-Sep-2025 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rohan Chauhan |
| Designation |
Head Vitreo Retina Services |
| Affiliation |
Rising Retina Clinic |
| Address |
312–313, Iscon Centre,
Shivranjani Crossroads, Satellite
Ahmadabad
GUJARAT
380015
India |
| Phone |
9825203022 |
| Fax |
|
| Email |
rohan_28782@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Sumit Gupta |
| Designation |
Director, Clinical Operations |
| Affiliation |
Syneos Health India private Limited |
| Address |
4th,Block 2, DLF Downtown, Commercial Site Bock V
DLF city Phase 3, Sector 25A,
Gurgaon
HARYANA
122002
India |
| Phone |
9560453771 |
| Fax |
|
| Email |
sumit.gupta@syneoshealth.com |
|
Details of Contact Person
Public Query
|
| Name |
Ataur Rahman |
| Designation |
Manager, Clinical Operations |
| Affiliation |
Syneos Health India private Limited |
| Address |
4th,Block 2, DLF Downtown, Commercial Site Bock V
DLF city Phase 3, Sector 25A,
Gurgaon
HARYANA
122002
India |
| Phone |
8532011805 |
| Fax |
|
| Email |
ataur.rahman@syneoshealth.com |
|
|
Source of Monetary or Material Support
|
| Alvotech Swiss AG
Thurgauerstrasse 54
8050 Zürich, Switzerland.
|
|
|
Primary Sponsor
|
| Name |
Alvotech Swiss AG |
| Address |
Thurgauerstrasse 54
8050 Zürich, Switzerland.
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Czech Republic
Georgia
Hungary
India
Latvia
Poland
Slovakia
Ukraine
Bulgaria |
Sites of Study
Modification(s)
|
| No of Sites = 11 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shorya Vardhan Azad |
All India Institute of Medical Science |
AIIMS, Ansari Nagar, New
Delhi-110029, India
New Delhi
DELHI |
9990026277
shoryaazad@gmail.com |
| Dr Naresh Babu Kannan |
Aravind Eye Hospital & Postgraduate Institute of Ophthalmology |
No. 1 Anna Nagar, Madurai – 625020, Tamil Nadu, India
Madurai
TAMIL NADU |
9443490920
cauveryeye@gmail.com |
| Dr Prakash Surendranath Vilakumadathil |
Comtrust Charitable Trust Eye Hospital |
Mini Bypass Road, Puthiyara
Calicut, 673004, Kerala, India
Kozhikode
KERALA |
9778425559
prakashvresearch@gmail.com |
| Dr Chaitra Jayadev |
Narayana Nethralaya |
121/C, Chord road,
Rajajinagar,1st R Block,
Bangalore –560010,
Karnataka, India
Bangalore
KARNATAKA |
9740066196
drchaitra@hotmail.com |
| Dr Lakshmi Mondal |
Regional Institute of Ophthalmology |
88, College Street, Medical
College and Hospital,
Kolkata –700073, West
Bengal, India
Kolkata
WEST BENGAL |
8017508356
lakshmi.mondal62@gmail.com |
| Dr Rohan Chauhan |
Rising Retina Clinic |
312–313, Iscon Centre, Shivranjani Crossroads, Satellite, Ahmedabad – 380015, Gujarat, India
Ahmadabad
GUJARAT |
9825203022
rohan_28782@yahoo.co.in |
| Dr Prabhu Shanker Mahalingam |
Sankara Eye Hospital |
16-A, Sathy Road, Sivanandapuram, Coimbatore- 641035, Tamil Nadu, India
Coimbatore
TAMIL NADU |
9443186568
prabhu@sankaraeye.com |
| Dr Sharad Bhomaj |
Shanti Saroj Netralay |
A.N. Gaikwad, 901/902, Beside Sundar Nagar, Anand Nursing Home Road, Miraj, Maharashtra – 416410, India
Sangli
MAHARASHTRA |
9960516364
sharadbhomaj@gmail.com |
| Dr Shobhana Mange |
Shivam Retina Clinic and Eye Hospital |
HG-1A, ITC Building, Majura Gate, Ring Road, Surat – 395001, Gujarat, India
Surat
GUJARAT |
9979530073
drshobhanamange@gmail.com |
| Dr Rahul Shroff |
Shroff Eye Hospital & Vision Research Centre |
222,S.V.Road, Bandra West,
Mumbai –400050, Maharashtra,
India
Mumbai
MAHARASHTRA |
9819421624
rahul@shroffeye.org |
| Dr Sheshadri Vishnu Mahajan |
St. Theresa’s Hospital |
Sanathnagar, Hyderabad –500018, Telangana, India
Hyderabad
TELANGANA |
8686494949
drsheshadri@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Ethics Committee, N.R.S. Medical College |
Approved |
| Ethics Committee, St. Theresa’s Hospital |
Approved |
| Institute Ethics Committee All India Institute of Medical Sciences |
Approved |
| Institutional Ethics Committee Comtrust Charitable Trust Eye Hospital |
Approved |
| Institutional Ethics Committee, Arvind Eye Hospital, No. 1 Anna Nagar, Madurai- 625 020 |
Approved |
| Institutional Ethics Committee, Sankara Eye Hospital |
Approved |
| Institutional Ethics Committee-Saishwari Clinic |
Approved |
| Medilink Ethics Committee |
Approved |
| Narayana Nethralaya Ethics Committee |
Approved |
| Shroff Eye Hospital Ethics Committee |
Approved |
| Unity Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H182||Other and unspecified corneal edema, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AVT29 |
AVT29 as a proposed biosimilar to Eylea 114.3 mg/mL (aflibercept).
Frequency : 8mg IVT D1, W4, W8 then every 8 to 16 weeks until W48.
Dose : 8 mg (0.07 mL of 114.3 mg/mL solution)
route of administration : Intravitreal injection.
Total duration : 48 weeks |
| Comparator Agent |
EYLEA HD |
Frequency : 8mg IVT D1, W4, W8 then every 8 to 16 weeks until W48.
Dose : 8 mg (0.07 mL of 114.3 mg/mL solution)
route of administration : intravitreal injection.
Total duration : 48 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
As specified in Protocol Section 4.2 and 4.3 (Inclusion and Exclusion Criteria). |
|
| ExclusionCriteria |
| Details |
As specified in Protocol Section 4.2 and 4.3 (Inclusion and Exclusion Criteria). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change from baseline to Week 8 in BCVA as measured by the ETDRS letter score. |
Week 8 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change from baseline
in BCVA as assessed
by ETDRS letter score
throughout the study |
Week 4, Week
12, Week 16,
Week 20,
Week 24,
Week 28,
Week 32,
Week 36,
Week 40,
Week 44,
Week 48, and
Week 52 |
|
|
Target Sample Size
|
Total Sample Size="256"
Sample Size from India="45"
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)
|
29/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
23/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="11"
Days="4" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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 randomized, double-masked, parallel-group, active-controlled, multicenter Phase 3 study evaluating the efficacy, safety, and immunogenicity of AVT29 (a proposed aflibercept 8 mg biosimilar) compared with Eylea HD in participants with Diabetic Macular Edema (DME). The study aims to demonstrate equivalent clinical efficacy and comparable safety and immunogenicity between AVT29 and the reference product. |