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Safety and Efficacy of Two Doses of OCUL101 Compared with Aflibercept in Patients 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

The study focuses on Neovascular age-related macular degeneration, a condition where abnormal blood vessels grow under the central part of the retina and can lead to vision loss. Two eye medicines are being compared: a new investigational drug called OCUL101, which works as an anti-VEGF and anti-Complement C5 agent to block blood‑vessel growth and inflammation, and the approved medicine aflibercept, given as a standard injection into the eye (intravitreal injection).

The purpose of the study is to see whether the new drug can improve vision better than the standard treatment. Participants will receive a series of injections over several months and will return for regular eye examinations to check safety and how well the eyes are responding.

Vision will be measured using best corrected visual acuity, which is the sharpness of sight when wearing the best glasses, recorded on an ETDRS chart, a special eye chart used in research. The thickness of the central retina, called central subfield macular thickness, will be assessed with a detailed eye scan called spectral domain optical coherence tomography. Additional tests may include dye‑based imaging of retinal blood vessels (fluorescein angiography), photographic pictures of the back of the eye (color fundus photography), and imaging that highlights certain retinal changes (fundus autofluorescence). These checks help determine any changes in the disease and monitor safety throughout the trial.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and randomization
After providing informed consent, you are entered into the study and randomly assigned to receive either ocul101 or the active comparator aflibercept. the assignment is concealed, so you will not know which medication you are receiving.
Step 2
Baseline assessments
Before any injection, a series of tests are performed to record the condition of your eye. these include a best corrected visual acuity (bcva) test using an etdrs chart, imaging of the retina with spectral domain optical coherence tomography (sd‑oct), and other standard eye examinations.
Step 3
First intravitreal injection
The first injection is given directly into the eye (intravitreal). if you are assigned to the test medication, the injection contains ocul101 at a dose of 10.4 mg in a solution for injection. if you are assigned to the comparator, the injection contains aflibercept at a dose of 2 mg in a solution for injection.
Step 4
Subsequent intravitreal injections
Two additional injections of the same medication are administered according to the study schedule, for a total of three intravitreal injections. the exact interval between injections follows the protocol defined by the study investigators.
Step 5
Week 16 follow‑up visit
At week 16 after the first injection, you return for repeat bcva testing and sd‑oct imaging. these measurements are used to evaluate early changes in vision and retinal thickness.
Step 6
Week 36 primary efficacy assessment
At week 36, a comprehensive evaluation is performed. bcva is measured again with the etdrs chart to determine the change from baseline, which is the primary efficacy endpoint of the study. additional safety checks, including monitoring for adverse events, are also conducted.
Step 7
Long‑term follow‑up through week 96
Periodic visits continue up to week 96. during these visits, sd‑oct imaging, fluorescein angiography, color fundus photography, and fundus autofluorescence are performed to assess retinal thickness, lesion size, and geographic atrophy. safety monitoring for adverse events continues throughout this period.
Step 8
Study completion
After the final week‑96 visit, the study concludes for each participant. all data collected during the trial are used to evaluate the safety and efficacy of the medication you received.

Who can join the trial?

8 criteria

Signed Informed Consent – you must sign a written agreement that shows you understand the study and agree to take part.
Age must be at least 50 years and no more than 89 years on the first day of the study.
You must be treatment‑naive for the new blood‑vessel growth (called CNV) caused by neovascular age‑related macular degeneration in the eye being studied, with or without an area of tissue loss known as geographic atrophy.
Your best corrected visual acuity (the sharpest vision you can achieve with glasses or contacts) must be between 70 and 24 letters on the ETDRS chart, which is roughly equivalent to 20/40 to 20/320 on a standard eye chart.
If you have confirmed geographic atrophy in the study eye, you can still join as long as you meet all other requirements.
The front parts of your eye (ocular media) must be clear enough, and your pupil must be widened (pupillary dilatation) so doctors can take good quality pictures of the retina to confirm the diagnosis.
Male participants who have a sexual relationship with a woman who could become pregnant must agree to use an approved method of contraception for the entire time they are in the study.
Female participants who could become pregnant must either agree to avoid heterosexual intercourse or use a reliable method of contraception that has a failure rate of less than 1 % per year, during treatment and for at least three months after the last dose.

Who cannot join the trial?

26 criteria

Having new blood vessel growth (called CNV) caused by anything other than age‑related macular degeneration, such as certain infections, eye injury, severe nearsightedness, or eye inflammation.
Any past eye disease of the central retina (the macula) that is not related to age‑related macular degeneration and that affects vision or causes fluid inside the eye.
Having a condition called central serous chorioretinopathy, where fluid builds up under the retina, at the time of screening.
Having a tear in the retinal pigment epithelium (the thin layer that supports the retina) that involves the central part of the retina (the macula).
Having inactive neovascular age‑related macular degeneration (nAMD) in the study eye, as shown by imaging tests.
Having any other eye problem (for example, lazy eye, missing lens, detached retina, cataract, diabetic eye disease, or a membrane on the retina that pulls on it) that the doctor believes could limit vision improvement or require treatment during the study.
Having bleeding inside the clear gel (vitreous) of the eye at the screening visit or on the first day of the study.
Having uncontrolled glaucoma, meaning eye pressure stays above 25 mm Hg despite using two or more pressure‑lowering medicines and may need surgery or laser treatment.
Having a prescription for glasses or contacts that shows more than 8 diopters (a measure of lens power) of nearsightedness (myopia) in the study eye.
Having had refractive (vision‑correcting) or cataract surgery where the eye’s prescription before surgery was stronger than –8 diopters of myopia in the study eye.
Having received any previous or current treatment for abnormal blood vessels, geographic atrophy, or other retinal problems, including injections (anti‑VEGF, steroids, etc.), laser therapy, photodynamic therapy, or eye surgery in the study eye.
Having cataract surgery or treatment for cataract‑related complications with steroid drops or YAG laser capsulotomy within the past three months in the study eye.
Having any other eye surgery or procedure (such as vitrectomy, glaucoma surgery, corneal transplant, or radiation treatment) in the study eye.
Having a non‑functioning other eye, defined as being able to see only hand motions or worse, or not having the other eye at all (being effectively one‑eyed).
Having a history of idiopathic (unknown cause) or autoimmune‑related uveitis (inflammation inside the eye) in either eye.
Having active eye inflammation or a suspected/active eye or surrounding‑eye infection at the screening visit.
Having a major illness or having undergone a major surgical procedure within one month before screening.
Having active cancer within the past 12 months, except for certain treated skin cancers, early‑stage cervical cancer, or low‑risk prostate cancer.
Needing to continuously use any medicines or treatments that are not allowed in this study.
Being treated systemically (throughout the body) for a suspected or active infection at screening, unless a preventive antibiotic is approved by the study doctor.
Having uncontrolled high blood pressure at rest during screening (systolic above 180 mm Hg or diastolic above 100 mm Hg).
Having had a stroke (cerebral vascular accident) or a heart attack (myocardial infarction) within the past six months.
Having any other disease, metabolic problem, physical exam finding, or lab result that could make the study drug unsafe, affect the study results, or put the participant at high risk for complications, as judged by the doctor.
Being pregnant, breastfeeding, or planning to become pregnant during the study.
Having had a severe allergic reaction (anaphylaxis) to a biologic medication or to any ingredient in the study drugs, the dye used for eye imaging, the eye‑dropping solutions, or the anesthetic or antimicrobial agents used in the study.
Participating in another investigational drug or device trial (except for vitamins or minerals) within three months before screening.

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Verified sites

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

Axon Clinical s.r.o.
Verified
Prague, Czechia
Fakultni Nemocnice Kralovske Vinohrady
Responsive
Prague, Czechia
Pauls Stradins Clinical University Hospital
Verified
Riga, Latvia

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Investigated drugs

OCUL101
is an experimental eye medicine that is injected directly into the eye (intravitreal injection). It is designed to block two substances that can cause damage in age‑related macular degeneration: a protein called VEGF that promotes abnormal blood vessel growth, and a part of the immune system called complement C5 that can cause inflammation. By targeting both of these pathways, the study is testing whether OCUL101 can improve vision and protect the retina in people with this eye disease.
Eylea
is an already approved treatment for age‑related macular degeneration that is also given by injection into the eye. It works by blocking VEGF, which helps to reduce the growth of abnormal blood vessels and leakage in the retina. In this trial, Eylea is used as the active comparator to see how well the new drug OCUL101 performs in comparison.

Aflibercept

What is already known about the treatment

OCUL101
OCUL101 is given by injection into the eye (intravitreal) as a sterile solution, typically at a dose of about 10 mg. It is still an investigational drug, currently being studied in Phase II/III trials and not yet approved for general use. The medication is being tested for treating neovascular age‑related macular degeneration, a condition that causes vision loss. It works by simultaneously binding to VEGF and complement C5 proteins, blocking signals that cause abnormal blood‑vessel growth and inflammation, and is classified as a bi‑specific antibody‑like “trap” with anti‑VEGF and anti‑complement activity.
Aflibercept
Aflibercept (Eylea) is administered by intravitreal injection using a pre‑filled syringe, usually at a 2 mg dose. It is an approved, widely used therapy for eye diseases such as neovascular age‑related macular degeneration. The drug acts as a decoy receptor that captures VEGF molecules, preventing them from stimulating the growth of harmful blood vessels in the retina. It belongs to the class of recombinant fusion proteins and is known as an anti‑VEGF agent.

Investigated diseases

Neovascular age-related macular degeneration (nAMD) - It is a type of age‑related macular degeneration in which abnormal blood vessels grow beneath the retina. These new vessels leak fluid and blood, leading to swelling and scar formation in the central part of the eye. The condition usually starts with early drusen changes and progresses to a choroidal neovascular membrane that gradually impairs sharp, central vision. Repeated leakage and scarring can cause distortion of straight lines and a blurry central spot, and over time the retina may develop areas of tissue loss known as geographic atrophy.