Clinical study to evaluate the handling and safety of AVT06 PFS in subjects with chorioretinal vascular disease (ALVOEYE-D).

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Alvotech Swiss AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Eye Diseases [C11]

Trial duration

11 Mar 2024 → 22 May 2025

Decision date (initial)

2023-11-06

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Alvotech Swiss AG

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Others

1. To demonstrate appropriate and safe handling of AVT06 PFS.
2. To evaluate ocular safety of AVT06 administered with the PFS.

Conditions and MedDRA coding

chorioretinal vascular disease (neovascular age-related macular degeneration [nAMD], diabetic macular edema [DME], myopic choroidal neovascularization [CNV], retinal vein occlusion [RVO] and diabetic retinopathy [DR])

Study design 2 periods

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Male or female ≥18 years old.
2. Subjects with diagnosis of nAMD (wet), DME, RVO, DR, or myopic CNV in the study eye, treatment naïve or already on aflibercept treatment or its marketed biosimilar.
3. Study eye, eligible for the treatment of aflibercept, will be selected by the Principal Investigator.
4. Subject or his/her legal representative, must be able to read, understand and sign an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form (ICF) before any study-specific procedures.
5. Willing and able to comply with all study procedures and be likely to complete the study.
6. Subjects must be able to follow the contraception requirements as defined: • A male subject must agree to use contraception during the treatment period and for at least 3 months after the last Intravitreal(ly) (IVT) injection of study treatment and refrain from donating sperm during this period. • A female subject is eligible to participate if she is not pregnant (see Appendix 6), not breastfeeding, not intending to become pregnant during the treatment period and for at least 3 months after the last IVT injection of study treatment, and refrains to donate eggs (ova, oocytes) or freeze/store eggs for the purpose of reproduction during this period. The subject should meet at least 1 of the following conditions applies: i) Not a woman of childbearing potential (WOCBP). OR ii) A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after the last IVT injection of study treatment.

Exclusion criteria 14

1. Evidence of active infections such as but not limited to blepharitis, keratitis, or conjunctivitis in either eye.
2. Any concurrent ocular condition in the study eye which, in the opinion of the Principal Investigator, could either increase the risk to the subject beyond what is to be expected from standard procedures of IVT injections, or which otherwise may interfere with the injection procedure or with evaluation of safety.
3. Active or suspected ocular or periocular infection, within 2 weeks prior to Baseline in either eye.
4. Active scleritis or episcleritis or presence of scleromalacia in either eye.
5. Any macular hole, presence or history of retinal detachment, retinal pigment epithelial tear, and probably neovascular glaucoma in either eye.
6. Previously treated with AVT06 and/or any other anti-VEGF treatment (administered either on the study eye or fellow eye and/or systemic) with the exception of aflibercept or its marketed biosimilar.
7. Any active intraocular inflammation or infection in either eye or history of intraocular inflammation or infection after past IVT injections with any agent in either eye.
8. History of or any current indication of excessive bleeding and recurrent hemorrhages, including any prior excessive intraocular (including subconjunctival) bleeding or hemorrhages after IVT injection or intraocular procedures in either eye.
9. Uncontrolled ocular hypertension (defined as intraocular pressure [IOP] ≥25 mmHg despite treatment with most antiglaucoma treatment tolerable) at Screening and Baseline visits in either eye.
10. Subjects with best-corrected visual acuity (BCVA) of <20/200 (<34 letters) as assessed by early treatment diabetic retinopathy study (ETDRS) letter score in both eyes at Screening and Baseline visits.
11. Treatment with any IVT injection in the study eye within 28 days prior to Baseline.
12. Previous therapeutic radiation in the study eye.
13. Any intraocular surgery in the study eye at any time during the past 3 months prior to Baseline.
14. Any prior extended-release therapeutic agent, or ocular drug-release device implantation (approved or investigational including steroids) in the study eye.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. Proportion of AVT06 injections successfully administered with PFS at Day 1. 2. Incidence of ocular TEAEs, AESIs, and SAEs associated with the study eye from Baseline to Week 4.

Investigational products

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

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Alvotech Swiss AG

Sponsor organisation

Alvotech Swiss AG

Address

Thurgauerstrasse 54

City

Zurich

Postcode

8050

Country

Switzerland

Scientific contact point

Organisation

Alvotech Swiss AG

Contact name

Riken Soni

Public contact point

Organisation

Alvotech Swiss AG

Contact name

Silvia Cirillo

Third parties 4

Locations

1 EU/EEA country · 3 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 14 files

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

Application history

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