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Status unknownNCT04782128Updated Oct 11, 2023

Evaluation of RC28-E Injection in Diabetic Retinopathy

A Phase 2 interventional study of RC28-E injection in Diabetic Retinopathy, sponsored by RemeGen Co., Ltd.. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-11.

Sponsored by RemeGen Co., Ltd. · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetic Retinopathy

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03

In context

Diabetic Retinopathy

791 studies on the registry are indexed under Diabetic Retinopathy; 139 are open to participants now.

This study's planned enrollment of 120 is above the median of 80 across 491 interventional studies indexed under Diabetic Retinopathy.

Browse Diabetic Retinopathy studies →

Lead sponsor

RemeGen Co., Ltd. is the lead sponsor of 80 studies on the registry; 39 are open to participants now.

Browse RemeGen Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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;

Exclusion criteria

Exclusion Criteria:

  • 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 ;
  • 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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    intravitreal 1.0mg RC28-E injection Q8

    Subjects received 1.0mg intravitreal RC28-E injection every 4 weeks for 3 visits followed by injections every 8 weeks.

    Biological: RC28-E injection

  • Experimental
    Experimental: intravitreal 1.0mg RC28-E injection PRN

    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.

    Biological: RC28-E injection

  • Experimental
    Experimental: intravitreal 2.0mg RC28-E injection Q8

    Subjects received 2.0mg intravitreal RC28-E injection every 4 weeks for 3 visits followed by injections every 8 weeks.

    Biological: RC28-E injection

  • Experimental
    Experimental: intravitreal 2.0mg RC28-E injection PRN

    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.

    Biological: RC28-E injection

Interventions

  • BiologicalRC28-E injection

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: At Week 24, 52

Secondary outcomes

  1. 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).

    Time frame: At Week 24, 52

  2. 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.

    Time frame: At Week 24, 52

  3. Mean Change from Baseline in Best Corrected Visual Acuity (BCVA);

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

    Time frame: Baseline up to week 52

  4. 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.

    Time frame: Baseline upto week 52

  5. Percentage of Participants Who Received Panretinal Photocoagulation (PRP) at Week24, 52;

    The percentage of participants who received panretinal photocoagulation (PRP).

    Time frame: At Week 24, 52

  6. Percentage of participants who undergoing Vitrectomy at Week24, 52;

    The percentage of participants who undergoing vitrectomy.

    Time frame: At Week 24, 52

  7. Frequency of administration RC28-E;

    Number of intravitreal injections

    Time frame: At Week 24, 52

  8. Safety of RC28-E injection

    Incidence of AE in ocular and non-ocular

    Time frame: Baseline upto week 52

07

Study locations

1 site
  • Beijing Hospital
    Beijing, Beijing Municipality 100730, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2021 (actual). Primary completion is estimated for May 2024, 36 months after the start.

Of 39 phase 2 interventional studies under Diabetic Retinopathy, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 41. This study's planned 36 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 1, 2021
First posted
Mar 4, 2021
StartActual
May 25, 2021
Primary completionEst.
May 2024
CompletionEst.
Jul 2024
Last update
Oct 11, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 11, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04782128
Lead sponsor
RemeGen Co., Ltd.
Responsible party
Sponsor
First posted
Mar 4, 2021
Start date
May 25, 2021
Primary completion
May 2024 (estimated)
Completion
Jul 2024 (estimated)
Last update
Oct 11, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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