CompletedPhase 4

To Evaluate the Efficacy and Safety of Combination Therapy With B55R1 and B55R2 Compared to B55R1 Monotherapy in Patients With NPDR

South Korea52 participantsStarted 2022-04-28

Plain-language summary

This study is planned to evaluate the efficacy and safety of combination therapy with B55R1 and B55R2 compared to B55R1 monotherapy in patients with non-proliferative diabetic retinopathy (NPDR).

Who can participate

Age range

19 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Subjects aged 19 years or older as of the date of written consent.
. Patients diagnosed with type 1 or type 2 diabetes.
. Subjects with mild to severe nonproliferative diabetic retinopathy (diabetic retinopathy), grade 2-5 hard exudates
. Subjects with a best-corrected visual acuity (BCVA) of 0.33 or higher as determined by visual acuity testing.
. Subjects with a central retinal thickness of 350 µm or less as determined by optical coherence tomography (OCT).
. Subjects who have received an explanation of the purpose and methods of this clinical trial and voluntarily consented to participate.

Exclusion criteria

. Patients with proliferative diabetic retinopathy (diabetic retinopathy) or other causes of retinopathy.
. Patients with uncontrolled diabetes or uncontrolled hypertension.
. Patients with the following ocular diseases or surgical procedures:
. Patients who have received intravitreal and periocular steroid injections, intravitreal injection of anti-VEGF antibodies (anti-VEGF treatment), or laser photocoagulation within 12 weeks of the date of administration of the investigational drug

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The proportion of subjects achieving a ≥1-step improvement in hard exudate grade at Week 24

Timeframe: Week 24

Trial details

NCT IDNCT07230184

SponsorAJU Pharm Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-08-14

View on ClinicalTrials.gov More Non-Proliferative Diabetic Retinopathy trials