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Clinical study to evaluate the handling and safety of AVT06 PFS in subjects with chorioretinal vascular disease (ALVOEYE-D).
EU CTIS ID: 2023-505225-13-00
What this study is testing
1. To demonstrate appropriate and safe handling of AVT06 PFS. 2. To evaluate ocular safety of AVT06 administered with the PFS.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility criteria
Who can join
- 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.
What rules you out
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Georgia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Georgia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.