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Diabetic Macular EdemaPhase 2NCT04782115

Evaluation of RC28-E Injection in Diabetic Macular Edema

A Phase 2 study testing intravitreal injection of RC28-E and Conbercept in people with Diabetic Macular Edema, run by RemeGen Co., Ltd. at 37 sites in China.

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 is a non-randomized, open-label, multicenter, 48-week study to investigate the efficacy, safety and pharmacokinetics of RC28-E injection in the treatment of patients with diabetic macular edema. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diabetic Macular Edema
What is being tested?
intravitreal injection of RC28-E and Conbercept
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
156 participants
Where
37 sitesChina
Study dates
17 Mar 2021to 31 Jul 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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Sign the consent form, willing and able to comply with clinic visits and study-related procedures;
  • Aged 18 years to 80 years, male or female;
  • Diabetes mellitus(type 1 or 2);
  • The study eye must followed:
  • Retinal thickening secondary to diabetes mellitus (DME) involving the center of the fovea; Decrease in vision determined to be primarily the result of DME and not to other causes.
  • BCVA score in the study eye of 73 to 24 using the ETDRS protocol at an initial testing distance of 4 meters.
  • The central subfield thickness ≥300μm in the center subfield as assessed on OCT by the reading center;
  • If both eyes meet the inclusion criterion, one eye with poor BCVA is selected as the study eye; the researchers judged that the fellow eye should not be treated with other anti-VEGF drugs recently.

Who cannot join

  • The macular edema caused by others instead of diabetes mellitus;
  • Structural damage to the center of the macula in the study eye that is likely to preclude improvement in BCVA following the resolution of macular edema including atrophy of the retinal pigment epithelium, subretinal fibrosis or scar, significant macular ischemia or organized hard exudates;
  • Current iris neovascularization, vitreous hemorrhage, tractional retinal detachment or epiretinal membrane involving the macula in the study eye;
  • Only one functional eye even if that eye is otherwise eligible for the study;
  • Evidence of periocular or intraocular inflammation or infection including infectious blepharitis, keratitis, scleritis, conjunctivitis, endophthalmitis or uveitis at screening assessment in either eye;
  • Previous treatment with anti-angiogenic drugs in either eye or system (ranibizumab, aflibercept, conbercept, etc) within 3 months of the Day 0;
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  • History of cardiovascular and cerebrovascular events within 6 months of screening visit: myocardial infarction, unstable angina pectoris, ventricular arrhythmias, New York heart association grade II + heart failure, stroke, etc.;
  • Uncontrolled clinical disease (such as severe psychiatric, neurological, cardiovascular, respiratory disease or other systemic diseases) and tumors;
  • Those who participated in clinical trials for 3 months or 5 half-lives of the investigational product (the longer the time) before the baseline period;
  • Those who considered unsuitable for enrollment by investigator.

Trial locations and contacts

37 sites in 1 country.

37 sites in 1 country

China37 sites

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100010

  • Beijing Aier Intech Eye Hospital

    Beijing, Beijing Municipality

  • Beijing Hospital

    Beijing, Beijing Municipality

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality

  • Peking University Third Hospital

    Beijing, Beijing Municipality

  • The Second Hospital of Jilin University

    Changchun, Jilin

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan

  • Xiangya Hospital Central South University

    Changsha, Hunan

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • The Second Affiliated Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality

  • The Second Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong

  • Zhongshan Ophthalmic Center of Sun Yat-sen University

    Guangzhou, Guangdong

  • The Affiliated Hospital of Guizhou Medical University

    Guiyang, Guizhou

  • The First Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang

  • The Second Hospital of Anhui Medical University

    Hefei, Anhui

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia

  • Huizhou Central People's Hospital

    Huizhou, Guangdong

  • CNPC Central Hospital

    Langfang, Hebei

  • Jiangxi Provincial People's Hospital

    Nanchang, Jiangxi

  • The Affiliated Eye Hospital of Nanchang University

    Nanchang, Jiangxi

  • The Affiliated Eye Hospital of Nanjing Medical University

    Nanjing, Jiangsu

  • Ruian People's Hospital

    Rui’an, Zhejiang

  • Shenyang He Eye Specialist Hospital

    Shenyang, Liaoning

  • The Fourth People's Hospital of Shenyang

    Shenyang, Liaoning

  • Shanxi Eye Hospital

    Taiyuan, Shanxi

  • The First Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Weifang Eye Hospital

    Weifang, Shandong

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

  • Hebei Eye Hospital

    Xingtai, Hebei

  • Yantai Yuhuangding Hospital

    Yantai, Shandong

  • People's Hospital of Ningxia Hui Autonomous Region

    Yinchuan, Ningxia

  • Henan Provincial Eye Hospital

    Zhengzhou, Henan

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

  • Zhengzhou Second Hospital

    Zhengzhou, Henan

  • The First People's Hospital of Zunyi

    Zunyi, Guizhou

Other trials in China

About this study

Official title: Protein by Dual Blockage of VEGF and FGF-2) in Subjects With Diabetic Macular Edema.

This is a non-randomized, open-label, multicenter, 48-week study to investigate the efficacy, safety and pharmacokinetics of RC28-E injection in the treatment of patients with diabetic macular edema.

Being tested
intravitreal injection of RC28-E, Conbercept

What participants receive

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

  • intravitreal injection of RC28-EBiological

    a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF

  • ConberceptBiological

    KH902(Conbercept）

Study groups in NCT04782115
Study groupRoleWhat they receive
1.0mg RC28-E injection Q8ExperimentalIn the loading phase (from week 0 to week 8), the study eye will receive intravitreal injection of 1.0 mg RC28-E every 4 weeks, for 3 consecutive times; From then on to the 48th week, the patients were visited every 4 weeks and given medicine every 8 weeks.
Receives: Biological: intravitreal injection of RC28-E
1.0mg RC28-E injection as neededExperimentalIn the loading phase (from week 0 to week 16), the study eye will receive intravitreal injection of 1.0mg RC28-E every 4 weeks, for 5 consecutive times;In the as needed (pro re nata,PRN)phase (from then on to week 48), the study eye will receive the same dose on an PRN schedule based upon the physician assessment in accordance with pre-specified criteria.
Receives: Biological: intravitreal injection of RC28-E
2.0mg RC28-E injection Q8ExperimentalIn the loading phase (from week 0 to week 8), the study eye will receive intravitreal injection of 2.0mg RC28-E every 4 weeks, for 3 consecutive times; From then on to the 48th week, the patients were visited every 4 weeks and given medicine every 8 weeks.
Receives: Biological: intravitreal injection of RC28-E
2.0mg RC28-E injection as neededExperimentalIn the loading phase (from week 0 to week 16), the study eye will receive intravitreal injection of 2.0mg RC28-E every 4 weeks, for 5 consecutive times;In the as needed (pro re nata,PRN)phase (from then on to week 48), the study eye will receive the same dose on an PRN schedule based upon the physician assessment in accordance with pre-specified criteria.
Receives: Biological: intravitreal injection of RC28-E
control groupExperimentalIn the loading phase (from week 0 to week 8), the study eye will receive intravitreal injection of Conbercept every 4 weeks, for 3 consecutive times;In the as needed (pro re nata,PRN)phase (from then on to week 48), the study eye will receive the same dose on an PRN schedule based upon the physician assessment in accordance with pre-specified criteria.
Receives: Biological: Conbercept

What is being measured

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

  1. Mean change from baseline in BCVA at 24 week;

    BCVA=Best-corrected visual acuity;Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

    Measured: Baseline,week 24

  2. Mean change from baseline in BCVA at 52 week;

    Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

    Measured: Baseline, Week 52

Secondary outcomes (7)

  1. Mean change from baseline in BCVA at every visit during treatment period;

    Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

    Measured: Baseline up to Week 52

  2. Mean change from baseline in central subfield thickness at 12, 24, 36, 52 week.

    Measurement of central subfield thickness by OCT.

    Measured: 12, 24, 36, 52 week.

  3. Percentage of subjects with VA improvement (who gained >0 letters, ≥5 letters, ≥10 letters, ≥ 15 letters in their BCVA) from baseline at 52 week;

    Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

    Measured: Baseline up to Week 52

  4. Percentage of subjects with VA worsen (who lost ≥5 letters, ≥10 letters, ≥15 letters in their BCVA) from baseline at 52 week;

    Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

    Measured: Baseline, Week 52

  5. Percentage of subjects with BCVA ≥ 68 letters(a visual acuity Snellen equivalent of 20/40 or better) at 52 week;

    Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.

    Measured: Baseline, Week 52

  6. Frequency of administration RC28-E;

    Number of intravitreal injections

    Measured: Baseline, Week 52

  7. Safety of RC28-E injection

    Incidence of AE in ocular and non-ocular

    Measured: Baseline up to Week 52

Timeline

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

  1. First posted4 Mar 2021
  2. Study start17 Mar 2021
  3. Primary completion31 Jul 2023
  4. Study completion31 Jul 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
156 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04782115
Sponsor's protocol ID
28C002
Status last verified
Dec 2023
First submitted
1 Mar 2021
Last updated
18 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Zhang W, Cheng S, Gu X, Liu X, Dai H, Zhuang W, Sun B, Gao L, Sun X, Zhang M, Song Z, Wang W, Li L, Chen H, Fang J, Chen Y. Simultaneous inhibition of fibroblast growth factor-2 and vascular endothelial growth factor-a with RC28-E in diabetic macular edema: a phase 2 randomised trial. Br J Ophthalmol. 2025 Jun 23;109(7):784-790. doi: 10.1136/bjo-2024-326006.

    PubMed 40122579

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing intravitreal injection of RC28-E and Conbercept in people with Diabetic Macular Edema, run by RemeGen Co., Ltd. at 37 sites in China.

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 8 inclusion and 10 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 18 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in China. 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?

Mean change from baseline in BCVA at 24 week; (time frame: Baseline,week 24). 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 NCT04782115, which also lists 1 linked publication.

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 18 Dec 2023.

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