Advertisement

Topics

A Randomized, Double-masked, Multicenter, Controlled Study of Intravitreal KH902 in Patients With Neovascular Age-related Macular Degeneration (AMD)

2014-07-23 21:08:32 | BioPortfolio

Summary

This study is designed to access the safety and efficacy of multiple injections of KH902 at variable dosing regimens in patients with choroidal neovascularization due to neovascular age-related macular degeneration.

Description

Age related macular degeneration (AMD) is the leading cause of severe vision loss in people over the age of 65 in the United States and other western countries. A quantity of documents indicate that neovascularization promoted by vascular endothelial growth factor (VEGF) is main cause of visual acuity decline. Patients are starving for a new drug which can notably improve VA with less administration frequency and lower treatment cost. The new drug Recombinant Human VEGF Receptor-Fc Fusion Protein (KH902) is a gene fusion protein. The pre-clinical researches and phase I study show that KH902 is effective and safe in inhibiting the growth, migration, pullulation of vascular endothelial cells and neovascularization induced by VEGF. This study is designed to confirm the efficacy and safety of multiple injections of KH902 at variable dosing regimen in patients with choroidal neovascularization due to neovascular age-related macular degeneration. Based on the characteristics of KH902 and results from KH902 Phase I study as well as reference to clinical trials of similar drugs, it is determined that KH902 is administrated at 0.5mg/eye/time and 2.0mg/eye/time.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Neovascular Age-related Macular Degeneration

Intervention

intravitreal injection of KH902

Location

Optometry and Ophthalmology Hospital of Wenzhou Medical College
Wenzhou
Fujian
China
325027

Status

Active, not recruiting

Source

Chengdu Kanghong Biotech Co.,Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:32-0400

Clinical Trials [1564 Associated Clinical Trials listed on BioPortfolio]

Study of Intravitreal REGN2176-3 in Patients With Neovascular ("Wet") Age-Related Macular Degeneration (AMD)

The primary objective of the study is to explore the effect of REGN2176-3 on the Early Treatment Diabetic Retinopathy Scale (ETDRS) best-corrected visual acuity (BCVA) in patients with neo...

Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular Age-related Macular Degeneration (PANDA-2)

The purpose of this clinical study is to evaluate the efficacy and safety of two different levels of conbercept intravitreal (IVT) injection as compared to the approved vascular endothelia...

Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular Age-related Macular Degeneration (PANDA-1)

The purpose of this clinical study is to evaluate the efficacy and safety of two different levels of conbercept intravitreal (IVT) injection as compared to the approved vascular endothelia...

Anti-angiOpoeitin 2 Plus Anti-vascular eNdothelial Growth Factor as a therapY for Neovascular Age Related Macular Degeneration: Evaluation of a fiXed Combination Intravitreal Injection

The primary objective of the study is to compare the efficacy of intravitreal (IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI).

Blood Coagulation Parameters in Patients Receiving Intravitreal Aflibercept for Age-related Macular Degeneration

This study aims to evaluate coagulation parameters in treatment naive patients with neovascular age-related macular degeneration (AMD). Treatment naive patients with neovascular AMD, sched...

PubMed Articles [12153 Associated PubMed Articles listed on BioPortfolio]

Characteristics of patients with neovascular age-related macular degeneration who are non-responders to intravitreal aflibercept.

To investigate the frequency and patient characteristics that influence anatomic response of intravitreal aflibercept in treatment-naïve neovascular age-related macular degeneration (AMD).

TWELVE-MONTH OUTCOMES OF INTRAVITREAL AFLIBERCEPT FOR NEOVASCULAR AGE-RELATED MACULAR DEGENERATION: Fixed Versus As-needed Dosing.

To compare the clinical outcomes of aflibercept used with a fixed schedule with a pro-re-nata (PRN) retreatment regimen in patients affected by neovascular age-related macular degeneration.

Subfoveal Choroidal Thickness as a Potential Predictor of Clinical Response to Stereotactic Radiotherapy for Neovascular Age-Related Macular Degeneration.

Stereotactic radiotherapy (SRT) is a new adjuvant treatment modality that has been shown to reduce the need for repetitive intravitreal injections (IVIs) in patients with neovascular age-related macul...

Long-term Regular Use of Low-dose Aspirin and Neovascular Age-related Macular Degeneration: National Sample Cohort 2010-2015.

The association between long-term cardioprotective aspirin use and neovascular age-related macular degeneration is controversial. This study was undertaken to estimate the risk of neovascular age-rela...

The treat-and-extend injection regimen versus alternate dosing strategies in age-related macular degeneration: a systematic review and meta-analysis.

To assess outcomes of the treat-and-extend (T&E) injection regimen for neovascular age related macular degeneration (AMD) as compared to either a monthly or a pro-re-nata (PRN) treatment strategy.

Medical and Biotech [MESH] Definitions

A form of MACULAR DEGENERATION also known as dry macular degeneration marked by occurrence of a well-defined progressive lesion or atrophy in the central part of the RETINA called the MACULA LUTEA. It is distinguishable from WET MACULAR DEGENERATION in that the latter involves neovascular exudates.

A recombinant humanized monoclonal antibody fragment that binds VEGF-A to prevent its binding to VEGFR-1 and VEGFR-2 receptors. This activity reduces vessel permeability and angiogenesis in the treatment of neovascular age-related MACULAR DEGENERATION.

Specialized ophthalmic technique used in the surgical repair and or treatment of disorders that include retinal tears or detachment; MACULAR HOLES; hereditary retinal disease; AIDS-related retinal infections; ocular tumors; MACULAR DEGENERATION; DIABETIC RETINOPATHY; and UVEITIS.

A retrogressive pathological change in the retina, focal or generalized, caused by genetic defects, inflammation, trauma, vascular disease, or aging. Degeneration affecting predominantly the macula lutea of the retina is MACULAR DEGENERATION. (Newell, Ophthalmology: Principles and Concepts, 7th ed, p304)

A form of RETINAL DEGENERATION in which abnormal CHOROIDAL NEOVASCULARIZATION occurs under the RETINA and MACULA LUTEA, causing bleeding and leaking of fluid. This leads to bulging and or lifting of the macula and the distortion or destruction of central vision.

More From BioPortfolio on "A Randomized, Double-masked, Multicenter, Controlled Study of Intravitreal KH902 in Patients With Neovascular Age-related Macular Degeneration (AMD)"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topic

Ophthalmology
Ophthalmology is the branch of medicine that is devoted to the study and treatment of eye diseases. As well as mild visual defects correctable by lenses, ophthalmology is concerned with glaucoma, uveitis and other serious conditions affecting the eye, ...


Searches Linking to this Trial