Diabetic RetinopathyPhase 2NCT04782128
Evaluation of RC28-E Injection in Diabetic Retinopathy
A Phase 2 study testing RC28-E injection in people with Diabetic Retinopathy, run by RemeGen Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, open-label, multicenter study of the efficacy and safety of RC28-E injection (a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2) in the treatment of patients with moderately severe to severe nonproliferative diabetic retinopathy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- RC28-E injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 25 May 2021to Jul 2024
- 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);
- Moderately severe to severe NPDR (DRSS levels 47 or 53) which was confirmed by the central reading center, and in whom PRP can be safely deferred by the investigator's judgement;
- BCVA score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better) using the ETDRS protocol at an initial testing distance of 4 meters;
- If both eyes meet the inclusion criterion, one eye with poor BCVA is selected as the study eye;
Who cannot join
- Presence of DME threatening the center of the macula (within 1,000 microns of the foveal center) in the study eye;
- Evidence of retinal neovascularization on clinical examination or FA;
- Any prior focal or grid laser photocoagulation (within 1,000 microns of the foveal center) or PRP in the study eye;
- Current ASNV, vitreous hemorrhage, tractional retinal detachment or epiretinal membrane involved the macular in the study eye;
- History of vitreoretinal surgery in the study eye;
- Active infectious blepharitis, keratitis, scleritis, conjunctivitis at the screening assessments in either eye ;
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- Previous treatment with anti-angiogenic drugs in either eye or system (ranibizumab, aflibercept, conbercept, etc) within 3 months of the Day 0 visit;
- Previous use of intraocular or periocular corticosteroids (such as triamcinolone acetonide, dexamethasone vitreous implant) in either eye within 6 months of day 0.
- Uncontrolled clinical disease (such as severe psychiatric, neurological, cardiovascular, respiratory disease or other systemic diseases) and tumors;
- Pregnant or lactating women, subjects who had family planning throughout the study period;
- Those who participated in clinical trials for 3 months or 5 half-lives of the investigational product (the longer the time) before theDay 0
- Those who considered unsuitable for enrollment by investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Multicenter Study of the Efficacy and Safety of RC28-E Injection in Subjects With Moderately Severe to Severe Nonproliferative Diabetic Retinopathy
This is a randomized, open-label, multicenter study of the efficacy and safety of RC28-E injection (a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2) in the treatment of patients with moderately severe to severe nonproliferative diabetic retinopathy.
- Conditions
- Diabetic Retinopathy
- Being tested
- RC28-E injection
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC28-E injectionBiological
a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF
| Study group | Role | What they receive |
|---|---|---|
| intravitreal 1.0mg RC28-E injection Q8 | Experimental | Subjects received 1.0mg intravitreal RC28-E injection every 4 weeks for 3 visits followed by injections every 8 weeks. Receives: Biological: RC28-E injection |
| Experimental: intravitreal 1.0mg RC28-E injection PRN | Experimental | Subjects received 1.0mg intravitreal RC28-E injection every 4 weeks for 5 visits followed by injections an as needed (PRN) schedule based upon the physician assessment in accordance with pre-specified criteria. Receives: Biological: RC28-E injection |
| Experimental: intravitreal 2.0mg RC28-E injection Q8 | Experimental | Subjects received 2.0mg intravitreal RC28-E injection every 4 weeks for 3 visits followed by injections every 8 weeks. Receives: Biological: RC28-E injection |
| Experimental: intravitreal 2.0mg RC28-E injection PRN | Experimental | Subjects received 1.0mg intravitreal RC28-E injection every 4 weeks for 5 visits followed by injections an as needed (PRN) schedule based upon the physician assessment in accordance with pre-specified criteria. Receives: Biological: RC28-E injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who have improved by ≥2 steps from baseline in DRSS score at week 24, 52
The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at week 24, 52 from baseline
Measured: At Week 24, 52
Secondary outcomes (8)
Percentage of Participants Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Week 24, 52
Vision-threatening complications are defined as the composite outcome of proliferative diabetic retinopathy (inclusive of participants who have vitreous hemorrhage or tractional retinal detachment believed to be due to PDR) and anterior segment neovascularization (ASNV) (participants with neovascularization of the iris and/or definitive neovascularization of the iridocorneal angle).
Measured: At Week 24, 52
Percentage of Participants Who Developed Central Involved-Diabetic Macular Edema (CI-DME) at Week 24, 52;
The percentage of participants who developed CI-DME at week24, 52 were reported.
Measured: At Week 24, 52
Mean Change from Baseline in Best Corrected Visual Acuity (BCVA);
Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts.
Measured: Baseline up to week 52
Mean change from baseline in DRSS score;
The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at week 24, 52 from baseline.
Measured: Baseline upto week 52
Percentage of Participants Who Received Panretinal Photocoagulation (PRP) at Week24, 52;
The percentage of participants who received panretinal photocoagulation (PRP).
Measured: At Week 24, 52
Percentage of participants who undergoing Vitrectomy at Week24, 52;
The percentage of participants who undergoing vitrectomy.
Measured: At Week 24, 52
Frequency of administration RC28-E;
Number of intravitreal injections
Measured: At Week 24, 52
Safety of RC28-E injection
Incidence of AE in ocular and non-ocular
Measured: Baseline upto week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start25 May 2021
- Primary completionMay 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04782128
- Sponsor's protocol ID
- 28C003
- Status last verified
- Oct 2023
- First submitted
- 1 Mar 2021
- Last updated
- 11 Oct 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 11 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multicenter Study of the Efficacy and Safety of RC28-E Injection in Subjects With Moderately Severe to Severe Nonproliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT04782128
- Acronym / sponsor ID
- 28C003
- Conditions
- Diabetic Retinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 May 2021 (actual)
- Primary completion
- May 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 4 Mar 2021 (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.
This is a randomized, open-label, multicenter study of the efficacy and safety of RC28-E injection (a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF-2) in the treatment of patients with moderately severe to severe nonproliferative diabetic retinopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| intravitreal 1.0mg RC28-E injection Q8 | Experimental | Biological: RC28-E injectionSubjects received 1.0mg intravitreal RC28-E injection every 4 weeks for 3 visits followed by injections every 8 weeks. |
| Experimental: intravitreal 1.0mg RC28-E injection PRN | Experimental | Biological: RC28-E injectionSubjects received 1.0mg intravitreal RC28-E injection every 4 weeks for 5 visits followed by injections an as needed (PRN) schedule based upon the physician assessment in accordance with pre-specified criteria. |
| Experimental: intravitreal 2.0mg RC28-E injection Q8 | Experimental | Biological: RC28-E injectionSubjects received 2.0mg intravitreal RC28-E injection every 4 weeks for 3 visits followed by injections every 8 weeks. |
| Experimental: intravitreal 2.0mg RC28-E injection PRN | Experimental | Biological: RC28-E injectionSubjects received 1.0mg intravitreal RC28-E injection every 4 weeks for 5 visits followed by injections an as needed (PRN) schedule based upon the physician assessment in accordance with pre-specified criteria. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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);
- Moderately severe to severe NPDR (DRSS levels 47 or 53) which was confirmed by the central reading center, and in whom PRP can be safely deferred by the investigator's judgement;
- BCVA score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better) using the ETDRS protocol at an initial testing distance of 4 meters;
Key exclusion criteria (12 listed)
- Presence of DME threatening the center of the macula (within 1,000 microns of the foveal center) in the study eye;
- Evidence of retinal neovascularization on clinical examination or FA;
- Any prior focal or grid laser photocoagulation (within 1,000 microns of the foveal center) or PRP in the study eye;
- Current ASNV, vitreous hemorrhage, tractional retinal detachment or epiretinal membrane involved the macular in the study eye;
- History of vitreoretinal surgery in the study eye;
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 |
|---|---|---|
| RC28-E injectiona chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF | Biological | Experimental: intravitreal 1.0mg RC28-E injection PRN, Experimental: intravitreal 2.0mg RC28-E injection PRN, Experimental: intravitreal 2.0mg RC28-E injection Q8, intravitreal 1.0mg RC28-E injection Q8 |
Primary outcome
The proportion of subjects who have improved by ≥2 steps from baseline in DRSS score at week 24, 52
Time frame: At Week 24, 52
The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at week 24, 52 from baseline
8 secondary outcomes
Percentage of Participants Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Week 24, 52
Time frame: At Week 24, 52
Percentage of Participants Who Developed Central Involved-Diabetic Macular Edema (CI-DME) at Week 24, 52;
Time frame: At Week 24, 52
Mean Change from Baseline in Best Corrected Visual Acuity (BCVA);
Time frame: Baseline up to week 52
Mean change from baseline in DRSS score;
Time frame: Baseline upto week 52
Percentage of Participants Who Received Panretinal Photocoagulation (PRP) at Week24, 52;
Time frame: At Week 24, 52
Percentage of participants who undergoing Vitrectomy at Week24, 52;
Time frame: At Week 24, 52
Frequency of administration RC28-E;
Time frame: At Week 24, 52
Safety of RC28-E injection
Time frame: Baseline upto week 52
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RC28-E injection in people with Diabetic Retinopathy, 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 12 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 11 Oct 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 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?
Results are not available in the source record.
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 proportion of subjects who have improved by ≥2 steps from baseline in DRSS score at week 24, 52 (time frame: At Week 24, 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 11 Oct 2023.