A randomized study to evaluate the Efficacy and Safety of Intravitreal EYE103 Compared to Anti-VEGF

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Eyebiotech Limited

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

16 Oct 2025 → ongoing

Decision date (initial)

2025-06-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Eyebiotech Ltd

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Dose response, Safety, Efficacy, Therapy

The primary objective of the study is to demonstrate that EYE103 (0.5 mg or 0.8 mg) is non-inferior to ranibizumab 0.5 mg, as measured by the mean change in BCVA up to and including Week 52. This change will be measured using the standardized ETDRS chart from Day 1 to Year 1 (average of Weeks 48 and 52).

Conditions and MedDRA coding

Diabetic Macular Edema

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

IPD plan description

N/A

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Participants must be willing and able to understand the study procedures and the risks involved and provide written informed consent before the first study-related activity
2. Be male or female ≥18 years of age.
3. If female, have a negative serum pregnancy test at screening and further negative urine tests immediately before each dose of study medication if the participant is a female of childbearing potential (including those with <2 years since the onset of menopause, amenorrhea for <1 year, or not surgically sterile); such participants must agree to use a highly effective method of contraception from screening up to and including 3 months after the last dose of study drug (see Appendix B). She must also agree not to donate oocytes from screening up to and including 3 months after the last dose of study drug.
4. If male, be surgically sterile for at least 12 weeks, or agree to use an acceptable method of contraception, such as a condom, and a second highly effective method of contraception (see Appendix F) from Screening up to and including 90 days after the last dose of study drug (see Appendix B). He must also agree not to donate sperm from the time of the first dose until 12 weeks after the last dose of study drug.

Exclusion criteria 23

1. Be pregnant or breastfeeding.
2. Have history of cataract surgery and/or minimally invasive glaucoma surgery in the study eye within 90 days of screening.
3. Have any treatment for complications of cataract surgery with steroids or yttrium-aluminum garnet (YAG) laser capsulotomy within 90 days of Screening.
4. Have had pan-retinal photocoagulation or focal/grid thermal laser photocoagulation in the study eye within 90 days of screening.
5. Have any history of retinal detachment or treatment or surgery for retinal detachment in the study eye.
6. Have any history of uveitis in either eye.
7. Have significant media opacities, including cataract, in the study eye that might interfere with VA, assessment of safety, OCT, or fundus photography in the opinion of the reading center.
8. Have been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.
9. Have a cataract in the study eye that, in the judgment of the investigator is expected to require surgical extraction within 4 months of screening.
10. Have aphakia in the study eye.
11. Have an allergy to fluorescein dye.
12. Have had vitrectomy in the study eye.
13. Have active retinal disease other than the condition (DME/diabetic retinopathy) under investigation in the study eye.
14. Have active or suspected ocular or periocular infection or inflammation in either eye at day 1.
15. Currently have evidence of, or a history of any clinically significant autoimmune, cardiovascular, hematologic, hepatic, metabolic, peripheral vascular, renal, or respiratory disease, which, in the opinion of the investigator, would prevent the participant from completing the required assessments for this study.
16. Have a known hypersensitivity to any of the components of EYE103 formulation or prior hypersensitivity to mAbs.
17. Have had renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis or have renal failure anticipated to require hemodialysis or peritoneal dialysis at any time during the study.
18. Have previously participated in any study of EYE103.
19. Have uncontrolled blood pressure, defined as systolic ≥180 mmHg and/or diastolic ≥100 mmHg while a participant is at rest If a participant’s initial reading exceeds these values, a second reading may be obtained later the same day or on another day during the screening period. If the participant’s blood pressure is controlled by antihypertensive medication, the participant should be taking the same medication continuously for at least 30 days prior to Day 1.
20. Have history of stroke (cerebral vascular accident) or myocardial infarction within 180 days prior to Day 1.
21. Have any active malignancy.
22. Have any history of organ transplant.
23. If treatment-experienced for DME have a history of any of the following treatments within the noted time windows: • Have had prior treatment with 8 mg aflibercept (EYLEA HD) or faricimab (VABYSMO) within 120 days prior to the Screening visit in the study eye • Have had an IVT with other anti-VEGF treatments (ranibizumab, bevacizumab, aflibercept [2 mg], brolucizumab, pegaptanib sodium) in the study eye within 90 days of the Screening visit • Had prior IVT investigational agents in either eye at any time • Had treatment with ocriplasmin (JETREA®) in the study eye at any time • Had previous use of ILUVIEN® at any time, of OZURDEX® IVT implants within 180 days of the Screening visit, or any other intraocular or periocular corticosteroids in the study eye within 90 days of the Screening visit

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary endpoint is defined as the mean change in ETDRS BCVA from Baseline (Day 1) to Year 1 (average of Weeks 48 and 52).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Comparator 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Eyebiotech Limited

Sponsor organisation

Eyebiotech Limited

Address

120 Moorgate

City

London

Postcode

EC2M 6UR

Country

United Kingdom

Scientific contact point

Organisation

Eyebiotech Limited

Contact name

Loni Da Silva

Public contact point

Organisation

Eyebiotech Limited

Contact name

Loni Da Silva

Third parties 4

Locations

12 EU/EEA countries · 66 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 74 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications