Single-arm, open label, multicenter clinical study to evaluate the handling and safety of AVT06 pre-filled syringe (PFS) in subjects with chorioretinal vascular disease followed by an optional extension phase of AVT06 pre-filled syringe (PFS). - AVT06-GL-D01

Alvotech Swiss AG0 sites35 target enrollmentJuly 12, 2023

Conditionschorioretinal vascular disease (neovascular age-related macular degeneration [nAMD], diabetic macular edema [DME], myopic choroidal neovascularization [CNV], retinal vein occlusion [RVO] and diabetic retinopathy [DR])MedDRA version: 20.1Level: PTClassification code: 10012689Term: Diabetic retinopathy Class: 100000004853 MedDRA version: 20.0Level: PTClassification code: 10071129Term: Neovascular age-related macular degeneration Class: 100000004853 MedDRA version: 20.0Level: PTClassification code: 10038907Term: Retinal vein occlusion Class: 100000004853 MedDRA version: 20.1Level: LLTClassification code: 10057934Term: Diabetic macular edema Class: 10015919 MedDRA version: 21.1Level: LLTClassification code: 10073711Term: Myopic choroidal neovascularization Class: 10015919 Therapeutic area: Diseases [C] - Eye Diseases [C11]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: 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])
Sponsor: Alvotech Swiss AG
Enrollment: 35
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

July 12, 2023

End Date

TBD

Last Updated

last year

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Alvotech Swiss AG

Eligibility Criteria

Inclusion Criteria

•Male or female \=18 years old., 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., Study eye, eligible for the treatment of aflibercept, will be selected by the Principal Investigator., 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., Willing and able to comply with all study procedures and be likely to complete the study., 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

•Evidence of active infections such as but not limited to blepharitis, keratitis, or conjunctivitis in either eye., 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., Treatment with any IVT injection in the study eye within 28 days prior to Baseline., Previous therapeutic radiation in the study eye., Any intraocular surgery in the study eye at any time during the past 3 months prior to Baseline., Any prior extended\-release therapeutic agent, or ocular drug\-release device implantation (approved or investigational including steroids) in the study eye., 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., Active or suspected ocular or periocular infection, within 2 weeks prior to Baseline in either eye., Active scleritis or episcleritis or presence of scleromalacia in either eye., Any macular hole, presence or history of retinal detachment, retinal pigment epithelial tear, and probably neovascular glaucoma in either eye., 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., 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., 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., 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.