Age related macular degeneration with serosanguinous maculopathy without prior treatment Choroidal neovascularization and its complication at macular area AMD CNV BCVA
Conditions
Interventions
10th.12th months interrupting with sham in 3rd,
5th,
7th,
9th,
11th months.,Intraocular application of Bevazicumab in control eye group every month since the first visit to 12th months.
Active Comparator Drug,Active Comparator Drug
aflibercept,Bevazicumab
Intraocular application of Ziv-
aflibercept in study eye group on the the first visit,
1st,
2nd,
6th,
Sponsors
Ministry of public health
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age related macular degeneration with serosanguinous maculopathy without prior treatment 2.BCVA is between 78 and 24 which is equivalent to 20/32 to 20/320 in Snellen chart 3.Choroidal neovascularization and its complication at macular area 4.less than 50 percent of fibrosis in total lesion 5.no contraindication of intraocular Ziv-aflibercept and bevazicumab administration
Exclusion criteria
Exclusion criteria: 1.Inability to comply with study or follow-up procedures. 2. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation 3. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using effective methods of contraception during dosing of study treatment. Effective contraception methods include: -Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception -Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy) or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment -Male sterilization (at least 6 months prior to screening). For female patients on the study, the vasectomized male partner should be the sole partner for that patient -Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository -Use of oral, injected or implanted hormonal methods of contraception or other forms of hormonal contraception that have comparable efficacy (failure rate 160 mm Hg or diastolic value of >100 mm Hg while sitting at Screening or Baseline 9. Known hypersensitivity to: - Any of the study drugs (ranibizumab or verteporfin) or any component of their formulations or to drugs of similar chemical classes - Fluorescein or indocyanine green 10. Use of other investigational drugs within 30 d
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best corrected visual acuity 12th month standardized ETDRS chart | — |
Secondary
| Measure | Time frame |
|---|---|
| BCVA improvement (increased 5 letters) 1st,2nd,3rd,4th,5th,6th,7th,8th,9th,10th,11th,12th months ETDRS,leakage from abnormal vessels 6th,12th months IFA,ICGA,resolution of intraretinal fluid and subretinal fluid 6th,12th months SD-OCT,central retinal subfield thickness 12th month SD-OCT,number of intraocular bevazicumab administration 12th month case record form,number of intraocular Ziv-aflibercept administration 12th month case record form,Quality of life 1st visit, 3rd month,12th month VFQ-25,Saftety and tolerability of drug administration every month since the first visit case record form, IOP, fundus examination, SD-OCT | — |
Countries
Thailand
Contacts
Public ContactPaisan Ruamviboonsuk
Rajavithi hospital
Outcome results
None listed