Age-related macular degeneration
Conditions
Interventions
2:Photodynamic therapy with verteporfin
intravitreal bevacizumab and intravitreal triamcinolone acetonide for 12 months vs Triple therapy using photodynamic therapy with verteporfin, intravitreal 1.25mg bevacizumab injection and intravitrea
Sponsors
Hong Kong Eye Hospital
Eligibility
Sex/Gender
Male
Age
55 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Patients aged 55 years or more; 2. Neovascular AMD with active leakage involving the fovea on fluorescein angiography (FA) and/or indocyanine green angiography (ICGA); 3. Best-corrected visual acuity (BCVA) with ETDRS letter score of 68 to 4 letters (Snellen equivalent of 20/40 to 20/800) in the affected eye; 4. Patients physically fit to receive intravitreal injection; and 5. Informed consent. In patients with bilateral presentations, only the eye with more recent of symptoms will be recruited in the study and the fellow eye will be treated according to the patient's preference.
Exclusion criteria
Exclusion criteria: 1. Coexisting ocular pathology other than visually non-significant cataract 2. High myopia with refractive error of -6 dioptres or higher 3. Media opacities which affect fundus examination or OCT measurements; 4. Previous intraocular surgery except uncomplicated cataract extraction and posterior intraocular lens implantation; 5. Cataract extraction or laser procedure within 6 months of enrolment; 6. Failure to comply with follow up schedule; 7. PDT with verteporfin within 6 months in the study eye; 8. Anti-VEGF therapy including pegaptanib, bevacizumab and ranibizumab within 6 months in the study eye; 9. Previous submacular surgery or external beam radiation therapy; 10. History of fluorescein allergy; 11. History of prophyria; 12. Known sensitivity to verteporfin or bevacizumab; 13. History of uncontrolled glaucoma in the study eye (defined as intraocular pressure >=25 mmHg despite treatment with anti-glaucoma medication); 14. Aphakia with absence of the posterior capsule in the study eye; 15. Active intraocular inflammation in the study eye; and 16. Retinal pigment epithelial tear involving the macula in the study eye.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. number of intravitreal bevacizumab injections required during the 12 month period;;2. levels of aqueous angiogenesis-related growth factors including VEGF and PEDF;;3. retinal thickness measured by optical coherent tomography (OCT);;4. proportion of patients with moderate visual loss;;5 proportion of patients with stable or improvement in vision;;6. changes in fluorescein angiography (FA) findings;;7. number of photodynamic therapy during the study period;;8. number of IVTA during the study period; and;9. multifocal electroretinography (mfERG).; | — |
Primary
| Measure | Time frame |
|---|---|
| The best-corrected visual acuity (BCVA) measured by ETDRS letter score at 12 months;The best-corrected visual acuity (BCVA) measured by ETDRS letter score at 12 months; | — |
Countries
China
Contacts
Public ContactDr. Lai Yuk Yau Timothy
Outcome results
None listed