A randomized study to evaluate the Efficacy and Safety of Intravitreal EYE103 Compared to Anti-VEGF (in patients with Diabetic Macular Edema)

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

22 Nov 2024 → ongoing

Decision date (initial)

2024-11-18

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, Therapy, Efficacy, Safety

The primary objective of the study is to demonstrate non-inferiority of EYE103 (0.5 mg or 0.8 mg) to anti-VEGF 0.5 mg, as measured by mean change in best-corrected visual acuity (BCVA) up to and including Week 52. This change will be measured using the standardized ETDRS (Early Treatment of Diabetic Retinopathy Study) chart from Day 1 to Year 1 (average of Weeks 48 and 52).

Conditions and MedDRA coding

Diabetic Macular Edema

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. 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 (defined as any female who has begun menstruation and who is not permanently sterile, and is not postmenopausal [defined as a female who has not had a menstrual period for at least 12 months without an alternative medical cause]); such participants must agree to use an acceptable method of contraception for 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

Exclusion criteria 29

1. Participants must not: Be pregnant or breastfeeding.
2. Have advanced or uncontrolled glaucoma in the study eye.
3. Have had glaucoma-filtering surgery (trabeculectomy or tube shunt) in the study eye.
4. Have any history of retinal detachment or treatment or surgery for retinal detachment in the study eye.
5. Have any history of uveitis in either eye.
6. Have significant media opacities, including cataract, in the study eye that might interfere with visual acuity, assessment of safety, OCT, or fundus photography in the opinion of the reading center.
7. 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.
8. Have aphakia in the study eye.
9. Have allergy to fluorescein dye.
10. Have had vitrectomy in the study eye.
11. Have known or former myopia with a spherical equivalent of >8 diopters.
12. Have had renal failure requiring renal transplant, hemodialysis, or peritoneal dialysis at any time during the study.
13. Have active retinal disease other than the condition (DME/diabetic retinopathy) under investigation in the study eye.
14. Have any history or evidence of a concurrent ocular condition present in the study eye that, in the opinion of the Investigator, could require either medical or surgical intervention or affect macular edema or alter visual acuity during the study
15. Have active or suspected ocular or periocular infection or inflammation in either eye at Day 1.
16. 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 exclude the participant from this study.
17. Have a known hypersensitivity to any of the components of EYE103 formulation or prior hypersensitivity to monoclonal antibodies (mAbs).
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
20. Have history of stroke (cerebral vascular accident) or myocardial infarction within 180 days prior to Day 1.
21. Are currently using of drugs with known retinal toxicity
22. Have history of cataract surgery and/or minimally invasive glaucoma surgery (MIGS) in the study eye within 90 days of Screening.
23. Have any treatment for complications of cataract surgery with steroids or Yttrium-Aluminum Garnet (YAG) laser capsulotomy within 90 days of Screening.
24. Have had Pan-retinal Photocoagulation (PRP) or focal/grid thermal laser photocoagulation in the study eye within 90 days of Screening.
25. Have tractional retinal detachment in the study eye.
26. Have any active malignancy
27. Have any history of organ transplant
28. Any ilicit drug use in the past 1 year
29. Had prior IVT complement inhibitors in either eye at any time

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

Sponsor responsibilities

Article 77 compliance

Eyebiotech Limited

Contact point sponsor

Eyebiotech Limited

Article 77 implementation

Eyebiotech Limited

Locations

12 EU/EEA countries · 68 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 90 files

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

Application history

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