AzTrials
AzTrials

Adults With Neovascular Age-related Macular DegenerationPhase 2/3STATNCT07520318

This is a 96-week, Multicenter Study in Patients With Neovascular AMD That Evaluates OCUL101 for Efficacy, Safety, Durability, and Pharmacokinetics, Comparing it With Another Treatment. The Study Will be Conducted in Two Parts, Part A and Part B.

A Phase 2/3 study testing bispecific anti-VEGF and anti-complement in people with Adults With Neovascular Age-related Macular Degeneration, run by Shenzhen Oculgen Biomedical Technology Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

Oculgen has begun a study of an investigational drug called OCUL101 as a possible treatment for neovascular AMD. An investigational drug is one that has not been approved by regulatory agencies, such as the Food and Drug Administration (FDA) in the United States (US), the European Medicines Agency (EMA) in the… Read more about this study

Who is it for?
Ages 50 to 89 years
What is being tested?
bispecific anti-VEGF and anti-complement
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
255 participants
Where
No sites listed yet
Study dates
17 Apr 2026to 29 Mar 2029
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 89 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet all the following criteria to be eligible for this study:
  • Signed Informed Consent
  • Age ≥50 and ≤89 years on Day 1/Baseline
  • Treatment-naive CNV secondary to AMD (nAMD), with or without geographic atrophy in the study eye.
  • Patients with neovascular AMD alone include: i. All MNV subtypes (Type 1, Type 2, Type 3, PCV). (Spaide 2020) ii. Subfoveal CNV or juxtafoveal CNV with a subfoveal component related to the CNV activity identified by FA or OCT (where CNV activity is defined as showing evidence of subretinal fluid, subretinal hyper reflective material, or leakage) iii. A total lesion size (including blood, atrophy, fibrosis, and neovascularization) of ≤ 9 disc areas on FA iv. A CNV component area of ≥50% of the total lesion size on FA b. Participants with nAMD and underlying and quantifiable geographic atrophy (GA) will be included if the following criteria are met: i. Total GA area on FAF between ≥2.5mm² and ≤17. mm² (~1-7 disc areas), If GA is multifocal, at least one lesion ≥1.25 mm² (~0.5 disc area).
  • GA lesion must be located within 1500 μm of the foveal center but not involving the fovea
Show all 11Show fewer
  • BCVA of 70 to 24 letters, inclusive (20/40 to 20/320 approximate Snellen equivalent), using the ETDRS protocol (see the BCVA manual for additional details) at Screening and Baseline in the study eye
  • Participants with confirmed underlying geographic AMD in the study eye at Screening or Baseline will be included in the study if all of the other criterion are met
  • Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis in the study eye
  • Male participants engaged in a sexual relationship with a woman of childbearing potential must be willing to use a medically accepted method of contraception from the duration of their participation in the study.
  • For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive measures that result in failure rate <1% per year during the treatment period and for at least 3 months after the final dose of study treatment i. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements ii. Examples of acceptable contraceptive methods include bilateral tubal ligation, male sterilization; hormonal contraceptives that inhibit ovulation, hormone releasing intrauterine devices; and copper intrauterine devices iii. Contraception methods that do not result in a failure rate of <1% per year such as male or female condom with or without spermicide; and cap, diaphragm, or sponge with spermicide are not acceptable iv. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the participants. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception

Who cannot join

  • Participants who meet any of the following criteria will be excluded from study entry:
  • CNV due to causes other than AMD, such as ocular histoplasmosis, trauma, pathological myopia, angioid streaks, choroidal rupture, or uveitis in either eye.
  • Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye.
  • Presence at screening of central serous chorioretinopathy in the study eye.
  • Retinal pigment epithelial tear involving the macula.
  • On FA/CFP/OCT/FAF: Inactive nAMD in the study eye:
Show all 35Show fewer
  • Subretinal hemorrhage of >50% of the total lesion area and/or that involves the fovea
  • Fibrosis of >50% of the total lesion area and/or that involves the fovea
  • Cystic degeneration (persistent intraretinal fluid or tubulations unresponsive to treatment)
  • Any concurrent intraocular condition (e.g., amblyopia, aphakia, retinal detachment, cataract, diabetic retinopathy or maculopathy, or epiretinal membrane with traction) that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study in the study eye.
  • Current vitreous hemorrhage at Screening and Day 1 in the study eye.
  • Uncontrolled glaucoma, defined as intraocular pressure >25 mmHg while on two or more pressure lowering medications and/or will require surgical intervention or laser treatment during the study in the study eye.
  • Spherical equivalent of refractive error demonstrating more than 8 diopters of myopia in the study eye.
  • For participants who have undergone prior refractive or cataract surgery, the preoperative refractive error should not have exceeded -8 diopters of myopia in the study eye.
  • Any prior or concomitant treatment for CNV, GA or vitreomacular-interface abnormalities, including, but not restricted to, IVT treatment (e.g., anti-VEGF, complement therapy, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air), periocular pharmacological intervention, argon laser photocoagulation, verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or ocular surgical intervention in the study eye.
  • Any cataract surgery or treatment for complications of cataract surgery with steroids or YAG (yttrium-aluminum-garnet) laser capsulotomy within 3 months prior to Screening in the study eye
  • Any other intraocular surgery or intervention (e.g., pars plana vitrectomy, glaucoma surgery, including minimally invasive glaucoma surgery [MIGS], corneal transplant, or radiotherapy)
  • Non-functioning non-study eye, defined as either:
  • BCVA of hand motion or worse
  • No physical presence of non- study eye (i.e., monocular)
  • History of idiopathic or autoimmune-associated uveitis in either eye
  • Active ocular inflammation or suspected or active ocular or periocular infection in either eye at the Screening visit.
  • Any major illness or major surgical procedure within 1 month before screening 28 Clinical Protocol OCUL101-002 Shenzhen Oculgen Biomedical Technology Co., Ltd. Protocol OCUL101-002, Version 2.0 Date: 12March2026
  • Active cancer within the 12 months prior to Screening except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, and prostate cancer with a Gleason score of < 6 and a stable prostate-specific antigen for > 12 months
  • Requirement for continuous use of any medications and treatments indicated in Section 6.6.1, Prohibited Therapy
  • Systemic treatment for suspected or active systemic infection at Screening.
  • Ongoing use of prophylactic antibiotic therapy may be acceptable if approved after discussion with the Medical Monitor
  • Uncontrolled blood pressure, defined as systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 100 mmHg while a participant is at rest at the Screening visit.
  • If a participant's initial reading exceeds these values, a second reading may be taken later on the same day or on another day during the screening period. If the participant's blood pressure is controlled by antihypertensive medication, the participant should be taking the same medication continuously for at least 30 days prior to Screening.
  • Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Screening.
  • History of other disease, metabolic dysfunction, physical examination finding, or historical or current clinical laboratory findings giving reasonable suspicion of a condition that contraindicates the use of the investigational drug or that might affect interpretation of the results of the study or renders the participant at high risk for treatment complications in the opinion of the investigator
  • Pregnancy or breastfeeding, or intention to become pregnant during the study
  • Women of childbearing potential must have a negative urine pregnancy test result within 28 days prior to initiation of study treatment. If the urine pregnancy test is positive, it must be confirmed by a serum pregnancy test.
  • History of a severe allergic reaction or anaphylactic reaction to a biologic agent or known hypersensitivity to any component of OCUL101 or aflibercept injections, study-related procedure preparations (including fluorescein), dilating drops, or any of the anesthetic and antimicrobial preparations used by a participant during the study
  • Participation in an investigational trial that involves treatment with any drug or device (with the exception of vitamins and minerals), including gene therapy or cell therapies, within 3 months prior to Screening.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Juliette Bridges, Sr. Director, Oculgen Biomedical contact

816-616-8130

juliette@oculgen.com.cn

William Zhou, Sr. Director, Oculgen Biomedical contact

About this study

Official title: A Phase II/III Multicenter, Randomized, Masked, Active Comparator-Controlled Study to Evaluate the Safety and Efficacy of Two Doses of OCUL101, an Anti-VEGF and Anti-Complement C5, Bi-specific Humanized Antibody-Like "Trap" in Participants With Neovascular Age-Related Macular Degeneration With or Without Geographic Atrophy - STAT Study

Oculgen has begun a study of an investigational drug called OCUL101 as a possible treatment for neovascular AMD. An investigational drug is one that has not been approved by regulatory agencies, such as the Food and Drug Administration (FDA) in the United States (US), the European Medicines Agency (EMA) in the European Union (EU), or others. A comparator drug, Eylea® (aflibercept), will also be used in this study. Aflibercept is approved by regulatory agencies to treat neovascular AMD.

VEGF-A (vascular endothelial growth factor A) is a protein released by the body in response to certain conditions that encourages the eye to form new blood vessels that are weak and leaky. This can lead to leakage of fluid and swelling in the macula; the part of the eye that helps you see clearly. C5 (component 5) is a part of the immune system released when there is ongoing damage to the eye such as when you have neovascular AMD. When it becomes too active in the eye, it can cause inflammation and further damage, leading to thinning of the back of the eye, a condition called geographic atrophy (GA). OCUL101 works by blocking both VEGF-A and C5.

Read more

The main purpose of this study is to see how safe and tolerable OCUL101 is and how well OCUL101 works in participants when compared with aflibercept. From here on, OCUL101 and aflibercept will be referred to as the "study drug." This study is divided into 2 periods: a screening period and a study treatment period. During each study period, you will have 1 or more visits with your study doctor at the center. The screening visit will last about 3 hours, and all other visits will last about 3 to 6 hours.

This study has 2 Parts. Part A uses the 10.4 mg dose of OCUL101 and Part B uses 2 doses of OCUL101 (6.5 mg and 10.4 mg) to compare with 2 mg of aflibercept.

Before any study-related tests and procedures can be done, you will be asked to read and sign this informed consent form, and then the study will begin with a screening visit. The purpose of the screening visit is to decide whether or not you meet the requirements to take part in this study. If you do not meet the requirements, the study doctor will explain why and will discuss other treatment options with you.

If the study doctor decides that you meet all of the requirements to be in this study, you will be assigned to either Part A or randomly assigned (like drawing straws) to one of the groups in Part B. You will then receive one of the following study treatment plans:

  • Part A, 10.4 mg of OCUL101
  • Part B, Group 1, 6.5 mg of OCUL101 + as needed study treatments of 10.4 mg OCUL101
  • Part B, Group 2, 10.4 mg of OCUL101
  • Part B, Group 3, 10.4 mg of OCUL101
  • Part B, Group 4, 2 mg of aflibercept You will receive 3 injections between Day 1 and Week 8, after which you may or may not receive additional injections every 8 weeks until Week 36. After you receive the set number of injections for your Part/group, you may receive additional injections during the study if the study doctor thinks it will help you.

You will have an 80% (4 in 5) chance of receiving OCUL101 and a 20% (1 in 5) chance of receiving aflibercept.

This is a double-masked study, which means you and some of the people involved in the study will not be told if you are receiving OCUL101 or aflibercept. However, this information will be given to the study doctor if it becomes necessary for your safety.

The eye receiving the study drug is called "the study eye". If the other eye, called the "fellow eye", needs treatment with anti-VEGF therapy, you can discuss this with your study doctor. This treatment may be provided during your study visit, if appropriate.

Description of the procedures and assessments

  • Medical history: Includes questions about any diseases, chronic or ongoing conditions, surgeries, cancer history, reproductive status, and smoking history. Any information about current or previous medicines will also be recorded.
  • Demographics: Information to be collected includes age, sex, and race/ethnicity.
  • Physical examination: Physical examination of the chest, abdomen, head and neck, and musculoskeletal system will be done as per your study doctor's preferred methods.
  • Eye examinations: Throughout the study you will have several eye tests. Both the front and back of your eye will be examined and some of these eye exams may occur in both eyes. Eye drops may be used to make your pupils (center part of your eye) look larger (dilated) and easier to look through.
  • BCVA: You will sit in front of an eye chart to read the letters and test the sharpness and accuracy of your vision.
  • Contrast sensitivity: You will sit in front of an eye chart read the letters where the letters are lighter and darker shades.
  • Color Vision Testing: Your vision will be tested to see how well you see color by having you look at color vision charts.
  • Assessment of metamorphopsia: Metamorphopsia is when you see lines as wavy or bent instead of straight.
Being tested
bispecific anti-VEGF and anti-complement
Keywords
wet age related macular degeneration, intraocular injection, anti-VEGF, anti complement, age between 50 and 89 years, US and Europe clinical sites

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bispecific anti-VEGF and anti-complementDrug

    Administered via injection.

Study groups in NCT07520318
Study groupRoleWhat they receive
Part A: Arm 1Active comparatorArm 1 (10.4 mg) of High Dose (HD) OCUL101, 80μL volume. One intravitreal injection every 4 weeks until Week 8 (Day 1, Week 4, Week 8) for a total of three injections, followed by one injection every 8 weeks up to Week 36, followed by assessment visits every 8 weeks and PRN (as needed) treatment until the end of the study (Week 96).
Receives: Drug: bispecific anti-VEGF and anti-complement
Part B: Arm 1Active comparatorArm 1 (6.5 mg) of Low Dose (LD) OCUL101, 50μL volume. One intravitreal injection every 4 weeks until Week 8 (Day 1, Week 4, Week 8) for a total of three injections, followed by one injection every 8 weeks up to Week-36, followed by assessment visits every 8 weeks and PRN (as needed) treatment with HD (10.4 mg) of OCUL101, 80μL volume until the end of the study (Week 96).
Receives: Drug: bispecific anti-VEGF and anti-complement
Part B: Arm 2Active comparatorArm 2 (10.4 mg) of High Dose (HD) OCUL101, 80μL volume. One intravitreal injection every 4 weeks until Week 8 (Day 1, Week 4, Week 8) for a total of three injections, followed by one injection every 8 weeks up to Week 36, followed by assessment visits every 8 weeks and PRN (as needed) treatment until the end of the study (Week 96)
Receives: Drug: bispecific anti-VEGF and anti-complement
Part B: Arm 3Active comparatorArm 3 (10.4 mg) of HD-3PRN OCUL101, 80μL volume. One intravitreal injection every 4 weeks until Week 8 (Day 1, Week 4, Week 8) for a total of three injections, followed by assessment visits every 8 weeks and PRN (as needed) until the end of the study (Week 96). If treatment with Test Agent is not needed, a Sham treatment must be given to maintain masking.
Receives: Drug: bispecific anti-VEGF and anti-complement
Part B: Arm 4Active comparatorArm 4 active comparator, aflibercept (2mg) as per US FDA Label, 50μL volume. One intravitreal injection every 4 weeks until Week 8 (Day 1, Week 4, Week 8) for a total of three injections, followed by one injection every 8 weeks until up to Week 36, followed by assessment visits every 8 weeks and PRN (as needed) treatment until the end of the study (Week 96).
Receives: Drug: bispecific anti-VEGF and anti-complement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]).

    The incidence and rate of adverse events (AEs), serious adverse events (SAEs), and treatment emergent adverse events (TEAEs).

    Measured: From enrollment to the end of treatment up to week 36, followed by assessment visits every 8 weeks and PRN treatment until the end of study (Week 96)

  2. Part B: Change from baseline in mean BCVA score.

    Change from baseline in mean best corrected visual acuity (BCVA) using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at Week 36 vs. active control (aflibercept 2mg).

    Measured: From enrollment followed by injection and assessments visits every 8 weeks and PRN treatment until the end of study (Week 96).

Secondary outcomes (6)

  1. Part A: Change in baseline in mean BCVA score.

    Change from Baseline in mean BCVA using the ETDRS chart after three intravitreal injections, and at Week 16

    Measured: From enrollment until week 16

  2. Part A: Change from Baseline in mean central subfield macular thickness (CST).

    Change from Baseline in mean central subfield macular thickness (CST), as documented by spectral domain coherence tomography (SD-OCT) after three intravitreal injections, to week 96.

    Measured: From enrollment to end of treatment at week 96.

  3. Part B: Mean change from baseline in CST.

    Mean change from Baseline in CST, as documented by SD-OCT vs aflibercept 2 mg at Week 36.

    Measured: From enrollment to Week 36.

  4. Part B: Proportion of participants with greater than or equal to 15-letter improvement in BCVA from baseline.

    Proportion of participants with greater than or equal to 15-letter improvement in BCVA from Baseline as measured by ETDRS chart at Week 36 vs. aflibercept 2 mg.

    Measured: From enrollment to Week 36.

  5. Part B: Percent change in CNV lesion size vs aflibercept.

    Percent change in choroidal neovascularization (CNV) lesion size (mm squared) vs aflibercept at Week 96 by fluorescein angiography (FA) and color fundus photography (CFP).

    Measured: From enrollment to Week 96.

  6. Part B: Change in square root of GA lesion size.

    Change in square root of geographic atrophy (GA) lesion size (mm squared) at Week 96 by fundus autofluorescence (FAF).

    Measured: From enrollment to Week 96.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2026
  2. Study start17 Apr 2026 (estimated)
  3. Primary completion1 Feb 2029 (estimated)
  4. Study completion29 Mar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel group; randomized, double-masked and controlled
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
255 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07520318
Sponsor's protocol ID
OCUL101-002
Acronym
STAT
Status last verified
Apr 2026
First submitted
3 Apr 2026
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing bispecific anti-VEGF and anti-complement in people with Adults With Neovascular Age-related Macular Degeneration, run by Shenzhen Oculgen Biomedical Technology Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Juliette Bridges, Sr. Director, Oculgen Biomedical (816-616-8130, juliette@oculgen.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]). (time frame: From enrollment to the end of treatment up to week 36, followed by assessment visits every 8 weeks and PRN treatment until the end of study (Week 96)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07520318.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in