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Efficacy and safety of ABP 938 compared with aflibercept in participants with neovascular age‑related macular degeneration

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Neovascular Age-related Macular Degeneration is an eye condition in which abnormal blood vessels grow under the central part of the retina, often leading to blurred or lost central vision. The study compares a new medicine called ABP 938 with an established medicine known as EYLEA® HD, which contains the active ingredient aflibercept. Both medicines are delivered by a tiny intravitreal injection, meaning the drug is placed directly inside the eye using a very small needle.

The purpose of the study is to determine whether the new medicine works as well as the existing one. Participants will receive a series of these eye injections over several months and will have regular eye examinations. Vision will be checked using a test called BCVA, measured with an ETDRS chart, which is a standardized eye chart used to assess how well a person can read letters. Doctors will also look for signs of fluid inside the retina, called IRF and SRF, and will measure the size of the abnormal blood‑vessel area, known as CNV, using imaging methods such as FA and SD-OCT. Safety will be monitored throughout the study, including checking for any immune reactions called ADAs.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit and eligibility confirmation
You will attend your first study visit after you have agreed to join the trial.
The study staff will check that you meet the required health criteria for neovascular age-related macular degeneration and will explain the procedures that will be performed.
Step 2
Baseline assessments
Before any medication is given, a series of tests will be performed to record your current eye condition.
These tests include a measurement of best‑corrected visual acuity (bcva), which evaluates how well you can see with your prescription glasses, and imaging of the retina using techniques such as optical coherence tomography and fluorescein angiography.
Step 3
Randomization to study medication
After baseline testing, you will be randomly assigned to receive either ABP 938 or EYLEA® HD.
Both medicines contain the same active substance, aflibercept, and each dose is 8 mg delivered as a solution for injection.
Step 4
First intravitreal injection
The first dose of the assigned medication will be given by an intravitreal injection, which means the drug is placed directly into the eye.
The injection contains 8 mg of aflibercept and is administered in a sterile setting by a qualified eye specialist.
Step 5
Scheduled follow‑up visits and additional injections
You will return to the study site for regular follow‑up visits according to the study schedule.
At each visit, the same eye tests performed at baseline (bcva measurement, retinal imaging) will be repeated to monitor changes in your vision and eye health.
Additional intravitreal injections of the same medication (8 mg) will be given at the visits that are defined in the study protocol.
The exact timing of these injections follows the trial schedule and continues for the duration of the study.
Step 6
Continuous safety monitoring
Throughout the trial, any new eye symptoms, general health problems, or side effects will be recorded and evaluated.
The study team will assess both ocular (eye‑related) and non‑ocular adverse events at each visit.
Step 7
Final study visit
At the end of the study period, you will attend a final visit that includes the same set of eye examinations performed at baseline.
The results from this visit will be used to compare the overall effectiveness and safety of the two medications.

Who can join the trial?

5 criteria

Be 50 years of age or older and be able to sign an informed consent form, which means you understand the study and agree to take part.
Have a new, untreated growth of abnormal blood vessels (called CNV) under or near the central part of the retina (subfoveal or juxtafoveal), caused by neovascular age‑related macular degeneration, confirmed by special eye imaging tests: spectral domain optical coherence tomography (SD‑OCT) and fluorescein angiography (FA).
The area of the abnormal blood vessels (CNV), including both “classic” and “occult” parts, must be larger than 50 % of the total lesion size in the study eye.
Your vision test result, measured as a best‑corrected visual acuity (BCVA) letter score, must be between 24 and 78 letters in the study eye.
There must be fluid inside the retina (intraretinal fluid) and/or under the retina (subretinal fluid) in the central 1 mm area of the study eye, as seen on the SD‑OCT scan.

Who cannot join the trial?

50 criteria

Large lesion size: Damage area larger than 12 disc areas (about 30.5 mm²) including blood, scars, or new vessels in the study eye, as seen on a special eye dye test.
Retinal detachment history in the study eye.
Macular hole of stage 2 or higher in the study eye.
Any macular problem that could limit vision, such as pulling on the retina (vitreomacular traction) or a thick membrane on the retina surface (epiretinal membrane) in the study eye.
Any eye surgery inside or around the eye within the past 12 weeks (84 days) before randomization, except eyelid surgery that can be within 4 weeks if it won’t affect the injection.
History of, or likely future need for, glaucoma surgeries such as tube shunt, trabeculectomy, or other filtration procedures in the study eye.
Uncontrolled glaucoma: eye pressure (intraocular pressure ≥ 25 mmHg) that does not respond to eye‑pressure medicines in the study eye.
No natural lens (aphakia) or artificial lens (pseudophakia) with a missing back capsule in the study eye, unless the capsule was removed by a YAG laser more than 30 days before screening.
Previous radiation treatment to the area of the study eye.
History of cornea transplant or corneal disease (corneal dystrophy) in the study eye.
Significant clouding of the eye’s media, such as cataract, that could interfere with measuring vision or safety.
Scar, fibrosis, or tissue thinning (atrophy) involving the central part of the study eye.
History of irregular astigmatism or amblyopia (lazy eye) that chronically limits best‑corrected vision in the study eye.
Any other eye condition besides nAMD in the study eye that would need planned medical or surgical treatment during the study, increase risk, or interfere with the injection or evaluation.
History or evidence of diabetic eye disease (diabetic retinopathy, diabetic macular edema), autoimmune eye inflammation (uveitis), or any other retinal blood‑vessel disease other than nAMD.
Active infection or inflammation outside or around the eye (e.g., blepharitis, keratitis, scleritis, conjunctivitis) in either eye at screening or randomization.
Any eye infection or inflammation in either eye within the past 12 weeks (84 days) before randomization.
Active inflammation of the white part of the eye (scleritis, episcleritis) or thinning of that tissue (scleromalacia).
Having only one functional eye (the other eye sees only “counting fingers” or less) or having a poor prognosis in the fellow eye.
Active systemic infection or a recent infection treated with antibiotics within 4 weeks before randomization, or chronic infections that could affect safety.
Uncontrolled high blood pressure (systolic ≥ 160 mmHg or diastolic ≥ 95 mmHg) that has not been stable for at least 12 weeks.
Heart attack or stroke within the past 24 weeks (168 days) before screening.
Scar or fibrosis involving more than 50 % of the total lesion in the study eye.
Kidney failure requiring dialysis or a kidney transplant at screening or likely during the study.
Any contraindication listed on the official prescribing information for aflibercept.
Uncontrolled serious systemic disease such as diabetes, heart disease (including moderate to severe heart failure, NYHA class III/IV), kidney disease, or liver disease that could affect results or increase risk.
Cancer diagnosed within the past 5 years, except cured skin cancers (basal or squamous cell), early‑stage cervical cancer, or early‑stage breast ductal carcinoma.
Any other serious disorder, condition, disease, or abnormal lab result that the investigator believes would put the participant at risk or interfere with the study.
Any prior or current eye or body treatment with anti‑VEGF or anti‑angiopoietin drugs, or eye surgery for nAMD, in the study eye (vitamins or supplements are allowed).
Long‑acting steroid use, either in the body or injected into the eye, within the past 16 weeks before screening, or any intravitreal implant, gene therapy, or cell therapy in the study eye at any time.
Intramuscular or intravenous corticosteroids within 4 weeks before randomization.
Vitreoretinal surgery (including scleral buckling) at any time in the study eye.
Use of ocriplasmin (JETREA®) at any time in the study eye.
Subretinal bleeding covering more than 50 % of the lesion area, or blood under the central vision spot (fovea) that is 1 disc area or larger in the study eye.
Any other eye surgery or pan‑retinal or macular laser treatment in the study eye within 12 weeks (84 days) before screening.
YAG laser capsulotomy in the study eye within 30 days before screening.
Prior investigational therapy in the fellow eye within 180 days before screening, or any intravitreal implant, gene therapy, or cell therapy at any time (standard anti‑VEGF treatment in the fellow eye is allowed).
Systemic anti‑VEGF treatment within 24 weeks (168 days) before screening.
Receiving an aflibercept injection in the fellow eye during the screening period.
Participation in another clinical study using an investigational product, or within 30 days (or 5 half‑lives) after the last dose of another investigational product.
For women who could become pregnant: being pregnant or breastfeeding, planning pregnancy, or not agreeing to use a highly effective birth‑control method during the study and for 4 months after the last dose.
For sexually active men who could father a child: not agreeing to use a highly effective birth‑control method during the study and for 3 months after the last dose, and agreeing not to donate sperm during that time.
Allergy or severe reaction to the study drug, its ingredients, or related procedures/medications (such as anesthesia, antiseptic, fluorescein dye).
Likely inability to attend all required study visits or follow study procedures.
Pigment epithelial detachment in the study eye larger than 400 µm, as seen on OCT imaging.
Being a member of the study site staff or an immediate family member.
Presence of retinal pigment epithelium tears or rips involving the macula in the study eye.
Vitreous hemorrhage (bleeding inside the eye) within 4 weeks before randomization in the study eye.
Other causes of choroidal neovascularization, such as severe nearsightedness (pathologic myopia), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study eye.
Prior vitrectomy (removal of the eye’s gel) or laser treatment of the macula (including photodynamic therapy or focal laser) in the study eye.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Fakultni Nemocnice Kralovske Vinohrady
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Prague, Czechia
Semmelweis University
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Budapest, Hungary
Vilniaus universiteto ligonine Santaros klinikos VšĮ
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Vilnius, Lithuania

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Investigated drugs

Eylea
is a medication that contains the active ingredient aflibercept. It is given as a sterile liquid that is injected directly into the eye (intravitreal injection). In this study, Eylea is used as the standard treatment (comparator) to see how well the new medication works compared with the established therapy for neovascular age‑related macular degeneration.
Aflibercept Biosimilar
(also referred to as ABP 938) is a medication designed to be very similar to aflibercept. Like Eylea, it is a sterile solution that is injected into the eye. In the trial, this biosimilar is the test product, and researchers are looking to see if it provides the same improvement in vision and safety as the standard aflibercept treatment.

Aflibercept

What is already known about the treatment

Eylea
Eylea is supplied as a clear solution that is injected directly into the eye (intravitreal injection). It is an approved and widely used medicine that is well documented in medical literature. It is used to treat neovascular age‑related macular degeneration, a disease that causes vision loss due to abnormal blood vessels in the retina. The drug works by attaching to proteins called VEGF that signal blood vessels to grow, thereby blocking new vessel formation; it belongs to the class of VEGF inhibitors (anti‑angiogenic agents).
Aflibercept Biosimilar
The aflibercept biosimilar is also a sterile solution given by intravitreal injection into the eye. It is a newer product that is being evaluated in clinical trials as a copy of the approved aflibercept medicine and is described in emerging medical literature. It is intended for the same condition, neovascular age‑related macular degeneration, to prevent vision loss from abnormal retinal vessels. Like the original, it binds to VEGF proteins to stop the growth and leakage of unwanted blood vessels and is classified as a VEGF inhibitor (anti‑angiogenic agent).

Investigated diseases

Neovascular age-related macular degeneration (nAMD) - A chronic eye condition in which abnormal blood vessels grow beneath the macula, the central part of the retina responsible for sharp vision. These new vessels tend to leak fluid or bleed, leading to swelling and damage of retinal tissue. Over time, the accumulation of fluid and scar tissue can cause a gradual loss of central visual clarity. The disease typically progresses from early signs of fluid buildup to more extensive retinal changes and persistent visual distortion. Patients may notice straight lines appearing wavy or a dark spot developing in the center of their view as the condition advances.