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Diabetic Macular EdemaPhase 2NCT05573100

The Study of CU06-1004 in Patients With Diabetic Macular Edema (DME)

A Phase 2 study testing CU06-1004 in people with Diabetic Macular Edema, run by Curacle Co., Ltd. at 11 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase 2a trial is a randomized, open-label, parallel-group study in approximately 60 patients with DME to evaluate the efficacy and safety of CU06-1004 orally administered once daily for 12 weeks. The study will have a 1:1:1 randomization (CU06-1004 100mg: CU06-1004 200mg: CU06-1004 300mg). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetic Macular Edema
What is being tested?
CU06-1004
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
11 sitesin 2 countries
Study dates
21 Dec 2022to 30 Jun 2023
Phase
Phase 2
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject who is male or female ≥ 18 years of age
  • Subject who has a diagnosis of Type 1 or 2 diabetes mellitus
  • Subject who has study eye with definite retinal thickening due to diabetic macular edema involving the center of the macula
  • Subject who has voluntarily signed an informed consent form
  • Subject who has study eye with central subfield thickness (CST) of the following on SD-optical coherence tomography (OCT).
  • Zeiss Cirrus: CST ≥ 290 µm in women, or ≥ 305 µm in men
Show all 10Show fewer
  • Heidelberg Spectralis: CST ≥ 305 µm in women, or ≥ 320 µm in men
  • Subject who has DRSS score ≥ 35
  • Subject who has study eye with an ETDRS BCVA letter score ranging from 34 to 83, inclusive (approximate Snellen equivalent of 20/25 - 20/200 at a distance of 4 meters).
  • Subject who has media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs.

Who cannot join

  • Subject whose macular edema is of non-diabetic retinopathy etiology (e.g., secondary to vitreomacular interface abnormalities).
  • Subject who has had major surgery within 3 months prior to randomization or major surgery planned during the next 6 months.
  • Subject who has a hypersensitivity to any excipients of the investigational product or similar class of drug and ingredient.
  • Subject who has the following illness or abnormal laboratory test values:
  • Uncontrolled hypertension (SBP > 180 mmHg or DBP > 100 mmHg)
  • Uncontrolled diabetes (HbA1c > 12.0%)
Show all 31Show fewer
  • Total bilirubin > 1.5 × ULN
  • Positive results for HIV or Hepatitis B or C viruses
  • Other clinically significant abnormal lab values per Investigator's judgement
  • Subject who participated in an investigational trial of biologic agent within 3 months and any other investigational trial within 1 month of randomization.
  • Subject who has received gene therapy for any indication.
  • Subject who has received COVID-19 vaccine within 30 days of first dosing until the end of the study.
  • Pregnant woman, lactating woman, or female or male subject of childbearing potential who doesn't accept appropriate contraceptive measures for the next 6 months
  • Hormonal contraceptives, intrauterine contraceptive device, sterilization of spouse (e.g., vasectomy, tubal ligation), double-barrier method (e.g., combinational use of spermicides and condoms, diaphragm, contraceptive sponge, or FemCap)
  • Subject who has medical condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
  • Subject who administered vaccinium myrtillus extract or dobesilate calcium within 2 weeks before randomization.
  • Subject who has unstable angina, myocardial infarction, transient ischemic attack, cerebral infarction, coronary artery bypass surgery, or transluminal coronary angioplasty within 6 months before screening.
  • Subject who has an ocular condition (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, foveal atrophy, pigmentary changes, dense subfoveal hard exudates, nonretinal condition etc.).
  • Subject who has exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis.
  • Subject who is expected to have no improvement of decreased visual acuity in the opinion of the Investigator, even if macular edema is resolved (e.g., foveal atrophy, abnormal pigmentation, dense subfoveal hard exudate).
  • Subject who has a history of treatment with anti-VEGF agents, or focal laser treatment (Focal/grid laser photocoagulation) within 3 months prior to randomization or intravitreal dexamethasone or triamcinolone within 6 months prior to randomization.
  • Subject who has a history of treatment with intravitreal fluocinolone astonide.
  • Subject who has a history of panretinal scatter photocoagulation (PRP).
  • Subject who anticipated need for PRP in the 3 months following randomization.
  • Subject who has a history of ocular surgery (including cataract extraction, any intraocular surgery, etc.) within prior 3 months or anticipated within the next 6 months following randomization.
  • Subject who has a history of retinal detachment or retinal detachment repair surgery.
  • Subject who has a history of YAG capsulotomy performed within 2 months prior to randomization.
  • Subject who has uncontrolled glaucoma in either eye (intraocular pressure (IOP) > 24 mmHg on medication or according to the investigator's judgment).
  • Subject who has a history of vitrectomy.
  • Subject who has any active intraocular inflammatory diseases such as uveitis, conjunctivitis, and in either eye.
  • Subject who has any history of intraocular inflammation in either eye other than what would be expected in the normal post-operative course following prior routine ocular surgery such as cataract surgery.

Trial locations and contacts

11 sites in 2 countries.

11 sites in 2 countries

United States10 sites

  • Austin Research Center for Retina

    Austin, Texas, 78705

  • Elman Retina Group

    Baltimore, Maryland, 21237

  • Retina consultant of Texas

    Bellaire, Texas, 77339

  • Mid Atlantic Retina

    Bethlehem, Pennsylvania, 18017

  • Ophthalmic Consultants of Boston

    Boston, Massachusetts, 02114

  • Rand Eye Institute

    Deerfield Beach, Florida, 33064

  • Cumberland Valley Retina Consultants

    Hagerstown, Maryland, 21740

  • Valley Retina Institute

    McAllen, Texas, 78503

  • Wagner Macula and Retina Center

    Norfolk, Virginia, 23454

  • New England Retina Consultants

    Springfield, Massachusetts, 01107

Other trials in United States

Puerto Rico1 site

  • Emanuelli Research & Development Center

    Arecibo, 00612

Other trials in Puerto Rico

About this study

Official title: A Randomized, Open-label, Parallel-group, Multi-center Phase 2a Study to Evaluate the Efficacy and Safety of CU06-1004 for 12 Weeks in Patients With Diabetic Macular Edema (DME)

This phase 2a trial is a randomized, open-label, parallel-group study in approximately 60 patients with DME to evaluate the efficacy and safety of CU06-1004 orally administered once daily for 12 weeks. The study will have a 1:1:1 randomization (CU06-1004 100mg: CU06-1004 200mg: CU06-1004 300mg).

Being tested
CU06-1004
Keywords
DME, Endothelial dysfunction blocker

What participants receive

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

  • CU06-1004Drug

    Also called SAC-1004, CU06, CU06-RE

    CU06-1004 per capsule for oral administration. CU06-1004 is a white off powder at room temperature. The CU06-1004 100 mg soft gelatin capsules consist of a solution-based fill.

Study groups in NCT05573100
Study groupRoleWhat they receive
CU06-1004 100mgExperimentalCU06-1004 100 mg tablets. Dosed at 100 mg (1 capsule) QD within 30 minutes after meal on each evening
Receives: Drug: CU06-1004
CU06-1004 200mgExperimentalCU06-1004 100 mg tablets. Dosed at 200 mg (2 capsules) QD within 30 minutes after meal on each evening
Receives: Drug: CU06-1004
CU06-1004 300mgExperimentalCU06-1004 100 mg tablets. Dosed at 300 mg (3 capsules) QD within 30 minutes after meal on each evening
Receives: Drug: CU06-1004

What is being measured

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

  1. The change of central subfield thickness (CST)

    Change in CST in the study eye assessed by SD-OCT at Week 12 compared to baseline

    Measured: Baseline and 12 weeks

  2. To determine the optimal doses

    The 1:1:1 randomization is fitting for the study objective to determine the optimal doses for a phase 2b study.

    Measured: 12 weeks

Secondary outcomes (6)

  1. The change of central subfield thickness (CST)

    Change in CST in the study eye assessed by SD-OCT Weeks 4 and 8 compared to baseline

    Measured: Baseline, 4 weeks and 8 weeks

  2. The change of all other subfield thickness

    Change in all other subfield thickness (Nasal, temporal, superior and inferior) in the study eye assessed by SD-OCT at Weeks 4, 8, and 12 compared to baseline

    Measured: Baseline, 4 weeks, 8 weeks and 12 weeks

  3. The change of early treatment diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA) letter score

    Change in ETDRS BCVA letter score in the study eye at Weeks 4, 8, and 12 compared to baseline

    Measured: Baseline, 4 weeks, 8 weeks and 12 weeks

  4. Change in diabetic retinopathy severity scale (DRSS)

    Change in DRSS in the study eye at Weeks 12 compared to baseline

    Measured: Baseline and 12 weeks

  5. The change of blood biomarkers

    Change in blood biomarker (TNF-alpha, IL-1 beta, IL-6) at Week 12 compared to baseline

    Measured: Baseline and 12 weeks

  6. Number and severity of treatment emergent adverse events (TEAEs)

    Number and severity of TEAEs up to Week 12 compared to baseline

    Measured: Baseline and 12 weeks

Timeline

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

  1. First posted10 Oct 2022
  2. Study start21 Dec 2022
  3. Primary completion31 May 2023
  4. Study completion30 Jun 2023

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
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05573100
Sponsor's protocol ID
CU06-RE-P2A-01
Status last verified
Jul 2023
First submitted
25 Sep 2022
Last updated
3 May 2024
Results posted
No
Data monitoring committee
No
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 study testing CU06-1004 in people with Diabetic Macular Edema, run by Curacle Co., Ltd. at 11 sites in 2 countries.

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 10 inclusion and 31 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: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

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 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.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change of central subfield thickness (CST) (time frame: Baseline and 12 weeks). 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 NCT05573100.

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 3 May 2024.

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