What is the mechanism of action of this treatment?

The most common treatments for Diabetic Macular Edema (DME) include anti-VEGF agents, corticosteroids, and laser therapy. Anti-VEGF agents, such as ranibizumab and aflibercept, work by inhibiting the VEGF protein, which is responsible for increased vascular permeability and abnormal blood vessel growth in the retina. Corticosteroids reduce inflammation and vascular leakage by inhibiting multiple inflammatory pathways. Laser therapy helps to seal leaking blood vessels and reduce retinal swelling. These treatments are crucial for DME patients as they directly address the mechanisms causing vision impairment, thereby helping to preserve and improve visual acuity.

What side effects are associated with this type of intervention?

Common treatments for Diabetic Macular Edema (DME) include anti-VEGF injections, corticosteroids, and laser therapy. Anti-VEGF injections, such as ranibizumab and aflibercept, can cause side effects like eye pain, increased intraocular pressure, and rare cases of endophthalmitis. Corticosteroids, such as dexamethasone implants, may lead to cataracts, increased intraocular pressure, and glaucoma. Laser therapy can result in temporary vision loss, scarring, and changes in color vision. For treatments similar to CU06-1004, which is an oral medication, side effects are less well-documented but may include systemic effects such as gastrointestinal discomfort or other non-ocular adverse reactions.

What prior FDA approvals exist?

The FDA has approved several treatments for Diabetic Macular Edema (DME), including anti-VEGF (vascular endothelial growth factor) agents such as ranibizumab (Lucentis), aflibercept (Eylea), and off-label use of bevacizumab (Avastin). These drugs work by inhibiting the growth of abnormal blood vessels and reducing fluid leakage in the eye. Additionally, corticosteroids like dexamethasone intravitreal implant (Ozurdex) and fluocinolone acetonide implant (Iluvien) are also approved for DME treatment, providing anti-inflammatory effects to reduce macular edema. These treatments have shown significant efficacy in improving visual acuity and reducing retinal thickness in patients with DME.

What other types of research exist?

Promising novel alternatives to CU06-1004 for Diabetic Macular Edema patients include: 1) Faricimab, a bispecific antibody targeting both VEGF-A and Ang-2, which has shown positive results in clinical trials. 2) Brolucizumab, a single-chain antibody fragment targeting VEGF-A, offering longer dosing intervals. 3) Gene therapy approaches like RGX-314, which aims to provide sustained anti-VEGF therapy through a single administration. These treatments are in advanced stages of clinical development and have demonstrated potential in improving visual outcomes and reducing treatment burden for DME patients.

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CU06-1004 for Diabetic Macular Edema

Phase 2

Waitlist Available

Research Sponsored by Curacle Co., Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 4 weeks, 8 weeks and 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests an oral medication called CU06-1004 on patients with Diabetic Macular Edema to see if it can reduce eye swelling and improve vision.

Who is the study for?

This trial is for adults over 18 with Type 1 or Type 2 diabetes who have swelling in the retina due to diabetic macular edema. Participants must have certain levels of retinal thickness and vision range, and be able to undergo eye photography. Exclusions include recent cardiovascular events, certain past treatments like intravitreal injections, uncontrolled health conditions, pregnancy, or not using contraception.

What is being tested?

The study tests CU06-1004's effectiveness and safety in treating diabetic macular edema when taken orally once a day for 12 weeks. There are three different dosage groups (100mg, 200mg, and 300mg), with patients randomly assigned to one of these groups in equal numbers.

What are the potential side effects?

While specific side effects for CU06-1004 aren't listed here, common side effects from similar oral medications may include gastrointestinal issues like nausea or diarrhea, potential liver function changes detectable by blood tests, fatigue or dizziness.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 4 weeks, 8 weeks and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 4 weeks, 8 weeks and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 4 weeks, 8 weeks and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To determine the optimal doses

Secondary study objectives

Change in diabetic retinopathy severity scale (DRSS)

Number and severity of treatment emergent adverse events (TEAEs)

The change of all other subfield thickness

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: CU06-1004 300mgExperimental Treatment1 Intervention

CU06-1004 100 mg tablets. Dosed at 300 mg (3 capsules) QD within 30 minutes after meal on each evening

Group II: CU06-1004 200mgExperimental Treatment1 Intervention

CU06-1004 100 mg tablets. Dosed at 200 mg (2 capsules) QD within 30 minutes after meal on each evening

Group III: CU06-1004 100mgExperimental Treatment1 Intervention

CU06-1004 100 mg tablets. Dosed at 100 mg (1 capsule) QD within 30 minutes after meal on each evening

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CU06-1004

2022

Completed Phase 2

~70

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Diabetic Macular Edema (DME) include anti-VEGF agents, corticosteroids, and laser therapy. Anti-VEGF agents, such as ranibizumab and aflibercept, work by inhibiting the VEGF protein, which is responsible for increased vascular permeability and abnormal blood vessel growth in the retina. Corticosteroids reduce inflammation and vascular leakage by inhibiting multiple inflammatory pathways. Laser therapy helps to seal leaking blood vessels and reduce retinal swelling. These treatments are crucial for DME patients as they directly address the mechanisms causing vision impairment, thereby helping to preserve and improve visual acuity.