Intravitreal Bevacizumab Combined With PDT (Full Fluence) Versus Bevacizumab to Treat Exudative Age-Related Macular Degeneration
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to 4 months
研究概览
简要总结
The purpose of this study is to determine the association of bevacizumab and PDT is safety and effective in the treatment of exudative AMD
详细描述
Exudative AMD is the leader of blind in people more than 60 years. The best treatment for this disease today are monthly injections of anti-VEGF in the vitreous cavity which increase the chance to get endophthalmites.
The participants of this study will be randomized in 1:1 ration to one of the two study groups: single therapy of bevacizumab (3 injections in 3 months) or association of bevacizumab (3 injections in 3 months) and full fluence of PDT (single at the baseline). All bevacizumab injection will contain 1.25g of the drug and will be administrate every month for 3 continuos months.
After randomization, participants will return to the clinic approximately every four weeks for 4 months for study assessments and possible re-treatment (if is necessary). Participants will return to the clinic at week 20 for a final study assessment. Study assessments include: visual acuity, optical coherence tomography and fundus photography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •more or iqual 50 years old
- •male or female
- •Choroidal neovascularization sub or just foveal the fovea secondary to AMD (Predominantly Classic, Minimally Classic, and Occult lesions acceptable)
- •Greatest linear dimension (GLD) of entire lesion < 5400 µm (no reading center confirmation required)
- •ETDRS best corrected visual acuity of 20/40 - 20/320 (73 - 24 letter score)
- •Total area of lesion must < 9 MPS DA
排除标准
- •pre-treatment
- •ETDRS best corrected visual acuity better than 34 letters
- •macular surgery history
- •laser photocoagulation in the study eye within 30 dais
- •eye surgery within 30 days
- •history of no-treat glaucoma
- •acuite uveits
- •history of endophthalmites
- •vitreous hemorrhage
- •geographic atrophy or fibrosis corresponding > 50% of the lesion
研究组 & 干预措施
1
干预措施: bevacizumab (Drug)
1
干预措施: vetaporfin (Drug)
2
干预措施: vetaporfin (Drug)
结局指标
主要结局
The mean change in best-corrected ETDRS visual acuity in the study eye from baseline to 4 months
时间窗: 4
次要结局
- Proportion of participants with reduction in retinal thickening in the center subfield (i.e., thickness > 200 microns) of ³50% and of at least 50 microns from baseline(4)
- The overall probability of re-injection(4)
- Mean change in area of leakage, CNV and lesion by the FA and ICG(4)