Diabetic Macular EdemaPhase 3NCT05885503
Efficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema
A Phase 3 study testing RC-28E and Aflibercept in people with Diabetic Macular Edema, run by RemeGen Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate efficacy and safety of RC28-E compared with Aflibercept in subjects with diabetic macular edema. 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?
- RC-28E and Aflibercept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteChina
- Study dates
- 8 Jun 2023to Jun 2026
- Phase
- Phase 3
- 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
- Documented diagnosed with type I or type II diabetes mellitus.
- Hemoglobin A1c (HBA1c) of less than or equal to (≤) 10% within 2 months prior to Day 1.
- Ability and willingness to undertake all scheduled visits and assessments.
- The study eye must meet the following requirements:
- macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea.
- decreased visual acuity attributable primarily to DME, the best corrected visual acuity (BCVA) 19 or more letters, 78 letters or less.
Who cannot join
- The study eye with high risk of proliferative diabetic retinopathy.
- The macular edema of the study eye is mainly caused by other diseases or factors other than DME.
- Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye.
- Administration of IVT any other anti-VEGF drugs in the study eye within 3 months and/or in the other eye within 7 days prior to Day 1.
- Any intraocular long-acting or sustained release corticosteroid treatment (e.g., dexamethasone intravitreal implant) in the study eye within 6 months prior to Day 1.
- Active intraocular or periocular infection or active intraocular inflammation in either eye.
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- The study eye with poorly controlled glaucoma.
- A history of idiopathic or autoimmune related uveitis in either eye.
- History of stroke (cerebrovascular accident) or myocardial infarction within 6 months prior to Day 1.
- Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest.
- Currently pregnant or breastfeeding, or intend to become pregnant during the study.
- Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye.
- Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye.
- Other protocol-specified inclusion/exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100010
Youxin Chen, M.D., 13801025972, chenyouxinpumch@163.com
About this study
Official title: A Phase III, Multicenter, Randomized, Double-blind, Active Controlled Trial of RC28-E Intravitreal Injection in Subjects With Diabetic Macular Edema
The purpose of this study is to evaluate efficacy and safety of RC28-E compared with Aflibercept in subjects with diabetic macular edema.
- Conditions
- Diabetic Macular Edema
- Being tested
- RC-28E, Aflibercept
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC-28EBiological
Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose.
AfliberceptBiological
Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose.
| Study group | Role | What they receive |
|---|---|---|
| RC-28E | Experimental | RC-28E 2.0 mg will be initially intravitreal injected (IVT) 5 times at 4 week intervals from week 0 to week 16, then every 8 weeks until week 48. Receives: Biological: RC-28E |
| Aflibercept | Active comparator | Aflibercept 2.0mg will be received IVT once every 4 weeks for 5 consecutive times from week 0 to week 16, then once every 8 weeks till week 48. Receives: Biological: Aflibercept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in BCVA at Week 52
BCVA=best-corrected visual acuity; Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a starting distance of 4 meters
Measured: Baseline, week 52
Secondary outcomes (15)
Average change in BCVA from baseline over the period week 40 through week 52
For each subject, this endpoint is defined as the average of the changes from baseline to weeks 40, 44, 48 and 52
Measured: Baseline, weeks 40, 44, 48 and 52
Change from baseline in BCVA over time
BCVA will be assessed at each visit
Measured: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of patients gaining >15, >10, >5, or >0 letters in BCVA from baseline at Week 52
Proportion of patients of gaining 4 types of letter counting in BCVA, respectively
Measured: Baseline, week 52
Proportion of patients avoiding a loss of >15, >10, >5, or >0 letters in BCVA from baseline at Week 52
Proportion of patients of reducing 4 types of letter counting in BCVA, respectively
Measured: Baseline, week 52
Change from baseline in CST at Week 52
CST=central subfield thickness
Measured: Baseline, week 52
Mean change from baseline in CST over a period of week 40 through week 52
CST=central subfield thickness
Measured: Baseline, weeks 40, 44, 48 and 52.
Change from baseline in CST over time
The change of CST will be assessed from baseline to 52 weeks by every 4 week intervals
Measured: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of patients with absence of intraretinal fluid at Week 52
Proportion of patients whose intraretinal fluid are completely improved
Measured: Baseline, week 52
Proportion of patients with absence of subretinal fluid at Week 52
Proportion of patients whose subretinal fluid are completely improved
Measured: Baseline, week 52
Proportion of patients with absence of intraretinal fluid and subretinal fluid at Week 52
Proportion of patients whose intraretinal fluid and subretinal fluid are both completely improved
Measured: Baseline, week 52
Proportion of patients with a >2-step or>3-step DRS worsening from baseline on ETDRS DRSS at Week 52
DRSS=Diabetic Retinopathy Severity Scale
Measured: Baseline, week 52
Proportion of patients who develop new PDR or high risk PDR at Week 52
PDR=proliferative diabetic retinopathy
Measured: Baseline, week 52
Incidence and severity of ocular adverse events and non-ocular adverse events
during the study
Measured: 0~52 weeks
Plasma concentration of RC28-E over time
during the study
Measured: Baseline, weeks 16, 36 and 48
Presence of ADAs during the study relative to the presence of ADAs at baseline
during the study
Measured: Baseline, weeks 12, 24, 36 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2023
- Study start8 Jun 2023
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by RemeGen Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 316 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Youxin Chen, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885503
- Sponsor's protocol ID
- 28C005
- Status last verified
- May 2023
- First submitted
- 19 May 2023
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Double-blind, Active Controlled Trial of RC28-E Intravitreal Injection in Subjects With Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT05885503
- Acronym / sponsor ID
- 28C005
- Conditions
- Diabetic Macular Edema
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 316 participants (estimated)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 2 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate efficacy and safety of RC28-E compared with Aflibercept in subjects with diabetic macular edema.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RC-28E | Experimental | Biological: RC-28ERC-28E 2.0 mg will be initially intravitreal injected (IVT) 5 times at 4 week intervals from week 0 to week 16, then every 8 weeks until week 48. |
| Aflibercept | Active comparator | Biological: AfliberceptAflibercept 2.0mg will be received IVT once every 4 weeks for 5 consecutive times from week 0 to week 16, then once every 8 weeks till week 48. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented diagnosed with type I or type II diabetes mellitus.
- Hemoglobin A1c (HBA1c) of less than or equal to (≤) 10% within 2 months prior to Day 1.
- Ability and willingness to undertake all scheduled visits and assessments.
- The study eye must meet the following requirements:
Key exclusion criteria (14 listed)
- The study eye with high risk of proliferative diabetic retinopathy.
- The macular edema of the study eye is mainly caused by other diseases or factors other than DME.
- Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye.
- Administration of IVT any other anti-VEGF drugs in the study eye within 3 months and/or in the other eye within 7 days prior to Day 1.
- Any intraocular long-acting or sustained release corticosteroid treatment (e.g., dexamethasone intravitreal implant) in the study eye within 6 months prior to Day 1.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RC-28EOphthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose. | Biological | RC-28E |
| AfliberceptOphthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose. | Biological | Aflibercept |
Primary outcome
Change from baseline in BCVA at Week 52
Time frame: Baseline, week 52
BCVA=best-corrected visual acuity; Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a starting distance of 4 meters
15 secondary outcomes
Average change in BCVA from baseline over the period week 40 through week 52
Time frame: Baseline, weeks 40, 44, 48 and 52
Change from baseline in BCVA over time
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of patients gaining >15, >10, >5, or >0 letters in BCVA from baseline at Week 52
Time frame: Baseline, week 52
Proportion of patients avoiding a loss of >15, >10, >5, or >0 letters in BCVA from baseline at Week 52
Time frame: Baseline, week 52
Change from baseline in CST at Week 52
Time frame: Baseline, week 52
Mean change from baseline in CST over a period of week 40 through week 52
Time frame: Baseline, weeks 40, 44, 48 and 52.
Change from baseline in CST over time
Time frame: Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Proportion of patients with absence of intraretinal fluid at Week 52
Time frame: Baseline, week 52
Proportion of patients with absence of subretinal fluid at Week 52
Time frame: Baseline, week 52
Proportion of patients with absence of intraretinal fluid and subretinal fluid at Week 52
Time frame: Baseline, week 52
Proportion of patients with a >2-step or>3-step DRS worsening from baseline on ETDRS DRSS at Week 52
Time frame: Baseline, week 52
Proportion of patients who develop new PDR or high risk PDR at Week 52
Time frame: Baseline, week 52
Incidence and severity of ocular adverse events and non-ocular adverse events
Time frame: 0~52 weeks
Plasma concentration of RC28-E over time
Time frame: Baseline, weeks 16, 36 and 48
Presence of ADAs during the study relative to the presence of ADAs at baseline
Time frame: Baseline, weeks 12, 24, 36 and 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Youxin Chen principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing RC-28E and Aflibercept in people with Diabetic Macular Edema, run by RemeGen Co., Ltd. at 1 site 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 6 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 5 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Binghua Xiao (86-010-58076833, xiaosir522@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in BCVA at Week 52 (time frame: Baseline, week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Sep 2023.