Neovascular age-related macular degeneration
Conditions
Interventions
Intervention Group:Bevacizumab 1.25mg intravitreal injection once eve
Comparator Group:Bevacizumab 1.25mg intravitreal injection once eve
Sponsors
Hospital Authority, Hong Kong
Eligibility
Sex/Gender
Male
Age
50 Years to 999 Years
Inclusion criteria
Inclusion criteria: 1. Adults of either sex aged >=50 years;2. Newly referred for the treatment of CNV caused by AMD in the first or second eye;3. Best corrected visual acuity >= 10 numbers/characters measured at 4 meters or >= 20 numbers/characters measured at 2 meters on a standard Early Treatment Diabetic Retinopathy Study (ETDRS) chart (provided there is no sign of long-standing CNV as evidenced by the presence of fibrosis occupying 50% of total lesion);4. CNV involving the centre of the fovea as diagnosed by fundus fluorescein angiography (FFA), indocyanine green angiography (ICGA), and optical coherence tomography (OCT);5. Voluntarily signs and dates an Informed Consent Form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific procedures.
Exclusion criteria
Exclusion criteria: 1. Long standing CNV evidenced by the presence of subretinal fibrosis in excess of 50% of the total lesion; 2. Presence of other active ocular diseases causing concurrent vision loss, e.g. diabetic retinopathy; 3. Previous treatment with photodynamic therapy (PDT), or intravitreal injection or systemic infusion of an anti-VEGF drug being considered for inclusion within the last 6 months; 4. Polypoidal choroidal vasculopathy (PCV); 5. High myopia >-6D; 6. Recent history (within 12 months) of stroke, myocardial infarction and thromboembolic event; 7. History of allergy to fluorescein dye, ranibizumab or bevacizumab; 8. Prior history of ocular surgery, except history of uneventful cataract surgery more than 4 months from time of randomization; 9. Uncontrolled glaucoma with intraocular pressure (IOP) >21mmHg despite medication; 10. Females who are pregnant or breastfeeding; 11. Women with childbearing potential not protected by effective contraceptive method of birth control and /or who are unwilling or unable to be tested for pregnancy. Females of bearing potential are defined as women who do not have a hysterectomy, bilateral oophorectomy, tubal ligation and/or who have not been post menopausal for at least two years; 12. Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening of this study; 13. Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best corrected visual acuit; | — |
Countries
China
Contacts
Public ContactWONG, David Sai Hung
Outcome results
None listed