A Randomized, Double-masked, Multicenter,Sham-controlled, Safety and Efficacy Study of KH902 in P… (NCT01436864) | Clinical Trial Compass
CompletedPhase 3
A Randomized, Double-masked, Multicenter,Sham-controlled, Safety and Efficacy Study of KH902 in Patients With Wet AMD
China125 participantsStarted 2011-08
Plain-language summary
This study is designed to prove and confirm the efficacy and safety of multiple injections of human recombinant vascular endothelial growth factor receptor-Fc fusion protein (KH902) in patients with choroidal neovascularization due to neovascular age-related macular degeneration by comparing intravitreal injections of KH902 with sham-injections.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Signed the Informed Consent Form;
* Age ≥ 50 years of either gender;
* Total lesion size ≤ 30 mm2 of the study eye;
* BCVA score of the study eye between 73 and 19 letters;
* Clear ocular media and adequate pupil dilation to permit good quality fundus photographic imaging.
* BCVA score of the fellow eye ≥ 19 letters.
Exclusion Criteria:
* Current or previous non-exudative AMD diseases which affect the inspection and measurement of macular or the central visual acuity;
* Subretinal hemorrhage area≥ 50% of total lesion size;
* Scar or fibrosis area in study eyes ≥ 50% of total lesion size; or central foveal scar、fibrosis or atrophy of macular in the study eye;
* Presence of retinal pigment epithelial tear, retinal macular tractional, macular epiretinal membrane, and diagnosed with polypoidal choroidal vasculopathy in the study eye;
* Previous anti-VEGF drug treatment in the study eye within six months preceding screening; or anti-VEGF treatment in the fellow eye within three months before screening;
* Previous intraocular or periocular operations, excluding operations on eyelid without hampering the intravitreal injection in the study eye;
* Previous ophthalmologic operations in the study eye;
* Current active inflammation or infection in either eye;
* Uncontrolled previous or current glaucoma in either eye, or previous glaucoma filtering operation in the study eye;
* Current systemic administrations which may lead to toxicity in the crystalline lens;
*…