Choroidal Neovascularization
Conditions
Keywords
PM-CNV ,Ranibizumab, Dosing Strategy
Brief summary
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).
Detailed description
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.
Interventions
DRUG0.5mg intravitreal ranibizumab
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
Sponsors
Zhongshan Ophthalmic Center, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* older then 18 years old * refractive error ≥ -6.0 diopters or axial length ≥ 26.0mm * active CNV due to high myopic which is the only reason cause visual loss confirmed by fluorescein fundus angiography * BCVA ≥ 24.0 and ≤73 letters at a starting distance of 4 meters using Early Treatment Diabetic Retinopathy Study visual acuity chart.
Exclusion criteria
* history of (a) stroke,(b) laser photocoagulation involved macular area in study eye, (c) intraocular treatment with corticosteroids or intraocular surgery or anti vascular endothelial growth factor or verteporfin photodynamic therapy within 6 months in study eye, or (d) hypersensitivity to ranibizumab or fluorescein * presence of active infectious disease or confirmed intraocular pressure ≥ 21.0 mmHg * pregnant or nursing women * uncontrolled high blood pressure ≥ 150/90 mmHg or uncontrolled fasting blood glucose ≥ 7 mmol/L
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Injection Number | 12 months | Total IRV injection number |
| Best corrected visual acuity (BCVA) | Change from baseline to 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Retinal sensitivities on microperimetry | Baseline and monthly after enrollment from baseline up to 12 months |
| Electrical response densities in the foveal on multifocal electroretinogram | Baseline, 3 months, 6 months and 12 months after enrollment. |
| Alterations of optic coherence tomography angiography | Baseline, 3 months, 6 months and 12 months after enrollment. |
| Retinal thickness on optic coherence tomography | Baseline and monthly after enrollment up to 12 months. |
| Leakage in lesion on fluorescein fundus angiography | Baseline, 3 months, 6 months and 12 months after enrollment. |
| Fixation stability on microperimetry | Baseline and monthly after enrollment from baseline up to 12 months |
Countries
China
Outcome results
None listed