An Exploratory Clinical Trial Evaluating the Tolerability and Efficacy of KH906 in Patients With Corneal Neovascularization
31. december 2019 opdateret af: Chengdu Kanghong Biotech Co., Ltd.
An Exploratory Clinical Trial Evaluating the Tolerability and Efficacy of Conbercept Eye Drops in Patients With Corneal Neovascularization
The first stage of this study will evaluates the tolerability of different concentrations of Conbercept eye drop to patients with corneal neovascularization.
The second stage of this study will evaluate the effectiveness of conbercept eye drop initially.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
39
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Hubei
-
Wuhan, Hubei, Kina, 430060
- Rekruttering
- Renmin Hospital of Wuhan University
-
-
Sichuan
-
Chengdu, Sichuan, Kina, 610000
- Rekruttering
- West China Hospital of Sichuan University
-
Kontakt:
- Deng yingping
- E-mail: Dyp588@163.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Signed the informed consent form, volunteered to participate in the trial and followed up according to the protocol.
- Ages from 18 to 75,male or female.
- Superficial or deep neovascularization induced by trauma/chemical burn/inflammation/corneal transplantation.
Exclusion Criteria:
- Subjects who had significant defect in the corneal epithelium.
- Study eye had been injected of anti-vegf drugs within 3 months before screening
- Study eye was performed surgery (except keratoplasty) within 3 months prior screening, or eye surgery was planned during this trial period.
- Oral glucocorticoid administration within 1 month prior screening (except for duration less than 7 days)
- Systemic use of anti-vegf drugs within 45 days prior to screening.
- Have history of abnormal coagulation, such as end-stage liver disease, or are taking anticoagulants（except aspirin）.
- Uncontrolled clinical problems such as canner etc..
- Unable or unwilling to use effective contraception.
- Positive blood tests for pregnancy (female subjects)
- Participated in drug clinical trials within 3 months before the first administration.
- The researchers think the participants were not suitable for this trail.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Ikke-randomiseret
- Interventionel model: Sekventiel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Conbercept eye drop (0.1mg/ mL)
Subjects in this arm will receive 0.1mg/mL Conbercept eye drop 4 times a day, one drop at a time.
|
In the first stage, subjects will be receive Conbercept eye drop.
In the second stage,subjests will revceive conbercept eye drop or placebo.
|
|
Eksperimentel: Conbercept eye drop (0.5mg/ mL)
Subjects in this arm will receive 0.5mg/mL Conbercept eye drop 4 times a day, one drop at a time.
|
In the first stage, subjects will be receive Conbercept eye drop.
In the second stage,subjests will revceive conbercept eye drop or placebo.
In the second stage, subjects will be receive Conbercept eys drop or a placebo.
|
|
Eksperimentel: Conbercept eye drop (1.0mg/ mL)
Subjects in this arm will receive 1.0mg/mL Conbercept eye drop 4 times a day, one drop at a time.
|
In the first stage, subjects will be receive Conbercept eye drop.
In the second stage,subjests will revceive conbercept eye drop or placebo.
In the second stage, subjects will be receive Conbercept eys drop or a placebo.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ocular and Systemic Safety: occurrence of ocular and systemic adverse events
Tidsramme: day 14
|
The occurrence of ocular and systemic adverse events was closely monitored over the course of this study.
Ocular adverse events were monitored through complete ocular examinations.
Systemic adverse events were identified with physical examinations.
|
day 14
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
The Size and Extent of Corneal Neovascularization Will be Measured by Computerized Image Analysis of Corneal Photographs Taken Throughout the Study
Tidsramme: day 14 and day 28
|
The efficacy of KH906 in the treatment of corneal NV was evaluated by comparing corneal photographs taken at baseline with corneal photographs taken at the follow-up visits.
Percent change from baseline was measured.
|
day 14 and day 28
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
18. juli 2019
Primær færdiggørelse (Forventet)
1. april 2020
Studieafslutning (Forventet)
1. december 2020
Datoer for studieregistrering
Først indsendt
25. december 2019
Først indsendt, der opfyldte QC-kriterier
31. december 2019
Først opslået (Faktiske)
2. januar 2020
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
2. januar 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. december 2019
Sidst verificeret
1. december 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KH906-40101
Plan for individuelle deltagerdata (IPD)
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