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NCT04985448
Real World Study of the Effectiveness and Safety of Conbercept Ophthalmic Injection in the Treatment of Retinopathy of Prematurity - Multicenter, Retrospective and Observational Study Based on Real World Data
trial in Retinopathy of Prematurity in 1,000 participants. Status unknown.
1 October 2022
Quick facts
| Lead sponsor | Chengdu Kanghong Biotech Co., Ltd. |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 1,000 |
| Start date | 1 September 2022 |
| Primary completion | 1 October 2022 |
| Estimated completion | 1 October 2022 |
| Sites | 2 locations across China |
Conditions studied
- Retinopathy of Prematurity — all drugs for Retinopathy of Prematurity →
Sponsor
Chengdu Kanghong Biotech Co., Ltd. — full company profile →
Who can join
Eligibility, any sex, with Retinopathy of Prematurity. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Main effectiveness indicators
Time frame: 24 weeks
Proportion of eyes with no active retinopathy of prematurity and no structural adverse outcome (within 24 weeks after the first treatment; active retinopathy of prematurity is defined as additional lesions, vascular tortuosity, crest and other lesions having no alleviation but trend of progress after clinical treatment and new blood vessels continuing to exist or new born; poor structural outcomes -
Main safety indicators
Time frame: 24weeks
The proportion of affected eyes with ocular AEs (within 24 weeks after the first treatment) -
Primary endpoint
Time frame: 24 weeks
To evaluate the proportion of eyes with inactive retinopathy of prematurity and without structural adverse outcomes at 24 weeks after the first treatment (inactive retinopathy of prematurity is defined as the reduction in additional lesions, vascular tortuosity, ridges and other lesions after clinical treatment, showing no trend of progression, no persistent or newly developed neovascularization;
Sponsor's own description
This study is a retrospective, multi-center real world study. The real world data comes from the electronic medical record system and disease database of the research centers .The patient's demographic information, disease information, clinical treatment status, efficacy evaluation and adverse events and so on will be collected and evaluated by applicability of the data, generated an analysis data set. Use the causal inference method of statistical analysis to observe the effectiveness and safety of intravitreal injection of Conbercept, and explore the effectiveness and safety of different doses in the treatment of retinopathy of prematurity.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04985448
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Retinopathy of Prematurity
Currently open trials in the same condition.
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- NCT06672913 — Impact of Standardized Skin-to-Skin Care on Clinical Outcomes in Infants Born ≤ 32 Weeks: A Multicenter Study · NA · recruiting
- NCT06109285 — Validation of i-ROP DL to Detect More Than Mild ROP · NA · active not recruiting
- NCT06315556 — An Observational Study to Collect Data on How Aflibercept (Eylea) Given Using a Paediatric Dosing Device is Used in Pret · recruiting
- NCT06265363 — Evaluation of the Frequency, Risk Factors, and Outcomes of ROP in Infants With a BW >1500 Grs or GA ≥33 Wks in Turkey. · recruiting
Other Chengdu Kanghong Biotech Co., Ltd. trials
Trials by the same sponsor.
- NCT06885645 — First-In-Human Study in Participants With Advanced Solid Tumors · Phase 1 · not yet recruiting
- NCT04990271 — A Clinical Study on the Efficacy and Safety of VEC Intravenous Chemotherapy Combined With Conbercept Intravitreal Inject · Phase 2 · unknown
- NCT04555304 — Phase 2 Study of KH903 in Patients With Advanced Gastric or Gastroesophageal Junction Adenocarcinoma As Second-Line Ther · Phase 2 · unknown
- NCT03630952 — Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-2) · Phase 3 · terminated
- NCT03577899 — Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular AMD (PANDA-1) · Phase 3 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04985448 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chengdu Kanghong Biotech Co., Ltd.
- Last refreshed: 15 September 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04985448.
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