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- RC28-E / Rongchang Pharma
Simultaneous Inhibition of Fibroblast Growth Factor-2 and VEGF-A With RC28-E in DME: A Phase 2 Randomized Trial (DEMAND) - Sep 24, 2024 - Abstract #AAO2024AAO_2395;
Incidence of ocular and non-ocular adverse events was comparable between RC28-E groups and the conbercept group. Conclusion RC28-E demonstrated efficacy and tolerability comparable with those of conbercept in DME.
- || RC28-E / Rongchang Pharma
P1 data, Journal: Safety and Efficacy of Multiple Escalating Doses of RC28-E for Neovascular Age-Related Macular Degeneration: A Phase 1b Trial. (Pubmed Central) - Jul 20, 2024
Conclusion RC28-E demonstrated efficacy and tolerability comparable with those of conbercept in DME. RC28-E was well tolerated and exhibited an overall favorable safety profile with evidence of improvements in BCVA and anatomical parameters.
- || RC28-E / Rongchang Pharma
Enrollment closed, Trial completion date, Trial primary completion date: Evaluation of RC28-E Injection in Diabetic Retinopathy (clinicaltrials.gov) - Oct 11, 2023
P2, N=120, Active, not recruiting, Sponsor: RemeGen Co., Ltd.
RC28-E was well tolerated and exhibited an overall favorable safety profile with evidence of improvements in BCVA and anatomical parameters. Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Jul 2024 | Trial primary completion date: Oct 2023 --> May 2024
- |||||| Eylea (aflibercept intravitreal) / Bayer, Regeneron, RC28-E / Rongchang Pharma
Enrollment open: Efficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema (clinicaltrials.gov) - Sep 5, 2023
P3, N=316, Recruiting, Sponsor: RemeGen Co., Ltd.
Recruiting --> Active, not recruiting | Trial completion date: Dec 2023 --> Jul 2024 | Trial primary completion date: Oct 2023 --> May 2024 Not yet recruiting --> Recruiting
- ||| RC28-E / Rongchang Pharma
Trial completion, Trial completion date, Trial primary completion date: Evaluation of RC28-E Injection in Diabetic Macular Edema (clinicaltrials.gov) - Aug 31, 2023
P2, N=156, Completed, Sponsor: RemeGen Co., Ltd.
Not yet recruiting --> Recruiting Recruiting --> Completed | Trial completion date: Dec 2023 --> Jul 2023 | Trial primary completion date: Nov 2023 --> Jul 2023
- |||||||||| Eylea (aflibercept intravitreal) / Bayer, Regeneron, RC28-E / Rongchang Pharma
New P3 trial: Efficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema (clinicaltrials.gov) - Jun 2, 2023
P3, N=316, Not yet recruiting, Sponsor: RemeGen Co., Ltd.
- |||||||||| Eylea (aflibercept intravitreal) / Bayer, Regeneron, RC28-E / Rongchang Pharma
New P3 trial: Efficacy and Safety of RC28-E Versus Aflibercept (clinicaltrials.gov) - Feb 14, 2023
P3, N=432, Recruiting, Sponsor: RemeGen Co., Ltd.
- || RC28-E / Rongchang Pharma
Trial completion: Evaluation of RC28-E Injection in Wet Age-related Macular Degeneration (clinicaltrials.gov) - Jan 10, 2022
P1/2, N=37, Completed, Sponsor: RemeGen Co., Ltd.
Recruiting --> Completed | Trial completion date: Dec 2023 --> Jul 2023 | Trial primary completion date: Nov 2023 --> Jul 2023 Active, not recruiting --> Completed
- || RC28-E / Rongchang Pharma
Trial completion: Evaluation the Pharmacokinetics,Safety,Tolerability of Single Intravitreal Injection RC28-E in Subjects With Wet Age-Related Macular Degeneration (clinicaltrials.gov) - Apr 27, 2021
P1, N=12, Completed, Sponsor: RemeGen
Active, not recruiting --> Completed Recruiting --> Completed
- | RC28-E / Rongchang Pharma
Enrollment closed: Evaluation of RC28-E Injection in Wet Age-related Macular Degeneration (clinicaltrials.gov) - Apr 27, 2021
P1/2, N=37, Active, not recruiting, Sponsor: RemeGen
Recruiting --> Completed Recruiting --> Active, not recruiting
- ||| RC28-E / Rongchang Pharma
Enrollment open: Evaluation of RC28-E Injection in Diabetic Macular Edema (clinicaltrials.gov) - Apr 27, 2021
P2, N=150, Recruiting, Sponsor: RemeGen
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- ||| RC28-E / Rongchang Pharma
Enrollment open: Evaluation of RC28-E Injection in Diabetic Retinopathy (clinicaltrials.gov) - Apr 27, 2021
P2, N=120, Recruiting, Sponsor: RemeGen
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- | RC28-E / Rongchang Pharma
Trial completion date, Trial primary completion date: Evaluation of RC28-E Injection in Wet Age-related Macular Degeneration (clinicaltrials.gov) - Apr 23, 2021
P1/2, N=36, Recruiting, Sponsor: RemeGen
Not yet recruiting --> Recruiting Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Oct 2020 --> Oct 2021
- |||| RC28-E / Rongchang Pharma
New P2 trial: Evaluation of RC28-E Injection in Diabetic Macular Edema (clinicaltrials.gov) - Mar 3, 2021
P2, N=150, Not yet recruiting, Sponsor: RemeGen
- |||| RC28-E / Rongchang Pharma
New P2 trial: Evaluation of RC28-E Injection in Diabetic Retinopathy (clinicaltrials.gov) - Mar 3, 2021
P2, N=120, Not yet recruiting, Sponsor: RemeGen
- | bleomycin / Generic mfg., BMS
Journal: Pharmacology Study of the Multiple Angiogenesis Inhibitor RC28-E on Anti-Fibrosis in a Chemically Induced Lung Injury Model. (Pubmed Central) - Sep 24, 2020
P1
RC28-E exhibits significant anti-fibrosis effects on Idiopathic pulmonary fibrosis (IPF) in vivo. Moreover, TGF-β induced fibroblast activation in vitro via the inhibition of the TGF-β downstream Smad pathway, thus providing potential therapeutics for clinical disease-related fibrosis-like IPF as well as chemotherapy-induced fibrosis in cancer therapy.
- || RC28-E / Rongchang
PK/PD data, Preclinical, Journal: In vivo characterization of RC28-E, a fusion protein targeting VEGF and bFGF: Pharmacokinetics and ocular distribution in primates. (Pubmed Central) - Jul 19, 2020
No drug accumulation after multiple administration was noticed, but low titers of antibody produce against RC28-E were detected. Overall, RC28-E exhibited high clinical value due to adequate pharmacokinetic profiling, safety and efficacy.
- | RC28-E / Rongchang Pharma
Trial completion date, Trial primary completion date: Evaluation the Pharmacokinetics,Safety,Tolerability of Single Intravitreal Injection RC28-E in Subjects With Wet Age-Related Macular Degeneration (clinicaltrials.gov) - Mar 4, 2020
P1, N=12, Recruiting, Sponsor: RemeGen
Overall, RC28-E exhibited high clinical value due to adequate pharmacokinetic profiling, safety and efficacy. Trial completion date: Dec 2019 --> Jun 2020 | Trial primary completion date: Dec 2019 --> May 2020
- || RC28-E / Rongchang Pharma
New P1/2 trial: Evaluation of RC28-E Injection in Wet Age-related Macular Degeneration (clinicaltrials.gov) - Feb 16, 2020
P1/2, N=36, Recruiting, Sponsor: RemeGen
- | RC28-E / Rongchang Pharma
Trial primary completion date: Evaluation the Pharmacokinetics,Safety,Tolerability of Single Intravitreal Injection RC28-E in Subjects With Wet Age-Related Macular Degeneration (clinicaltrials.gov) - Jan 17, 2019
P1, N=12, Recruiting, Sponsor: RemeGen
Trial completion date: Dec 2019 --> Jun 2020 | Trial primary completion date: Dec 2019 --> May 2020 Trial primary completion date: Dec 2018 --> Dec 2019
- || RC28-E / Rongchang Pharma
New P1 trial: Evaluation the Pharmacokinetics,Safety,Tolerability of Single Intravitreal Injection RC28-E in Subjects With Wet Age-Related Macular Degeneration (clinicaltrials.gov) - Dec 17, 2018
P1, N=12, Recruiting, Sponsor: RemeGen