ZhongShan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060, China
NCT Number: NCT03042871
The purpose of this study is to compare the efficacy (times of injection, change of visual acuity and Cva/ I) and safety (macular visual function and choroidal thickness) of different dosing of ranibizumab intravitreal injection (1+PRN vs. 3+PRN) in treating with pathological myopia choroidal neovascularization (PM-CNV).
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Phase 4
Guangzhou, Guangdong, 510060, China
PM is a common disease in east asia, while PM-CNV affect 5%-10% PM patients.PM-CNV has specific characteristics, including small dimensions and limited exudative manifestations comparing with age-related macular degeneration. However, treatment regimen and re-treatment criteria follow the PrONTO protocol. The question of the optimal dose and treatment regimen in myopic CNV management is still unresolved. There is no unequivocal evidence suggesting hat PRN treatment is more effective than a loading phase followed by an as-needed variable dosage regimen.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients received ranibizumab (0.5mg, Novartis AG, Basel, Switzerland) via a pars plana transcleral injection through 30-gauge needle at 3.5 to 4mm of inferotemporal limbus. Levofloxacin eye drops ( Cravit Eye Drops, Santen, Japan) was instilled 4 times a day in the study eye before the treatment at least 1 day. Povidone-iodine (5%, Luofushan Pharmaceutical Co., China) was applied to the conjunctiva bulbi and the fornices for at least 3 minutes before injection. Patients were instructed to continue the levofloxacin eye drops 4 times a day for 3 days
Other names: IVR 0.5mg
Time frame: 12 months
Total IRV injection number
Time frame: Change from baseline to 12 months
Time frame: Baseline and monthly after enrollment from baseline up to 12 months
Time frame: Baseline, 3 months, 6 months and 12 months after enrollment.
Time frame: Baseline, 3 months, 6 months and 12 months after enrollment.
Time frame: Baseline and monthly after enrollment up to 12 months.
Time frame: Baseline, 3 months, 6 months and 12 months after enrollment.
Time frame: Baseline and monthly after enrollment from baseline up to 12 months
Zhongshan Ophthalmic Center, Sun Yat-sen University
Other
Dosing Strategy of Intravitreal Ranibizumab for Myopia Choroidal Neovascularization: a Single Center Randomized Prospective Study
Acronym: SMILE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02307682
Choroid Diseases, Choroidal Neovascularization
Fort Worth, Texas, United States
View Trial DetailsNCT02434328
Choroid Diseases, Choroidal Neovascularization
View Trial DetailsNCT00967850
Choroid Diseases, Choroidal Neovascularization
Santiago de Compostela, La Coruña, Spain
View Trial DetailsNCT05662943
Age-Related Macular Degeneration, Choroid Diseases
Seoul, South Korea
View Trial Details