Acute Pseudophakic Cystoid Macular Edema Treatment Trial: Intravitreal Ranibizumab Versus Triamcinolone Acetonide
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- SAFETY of INTRAVITREAL RANIBIZUMAB VS. TRIAMCINOLONE ACETONIDE FOR ACUTE PSEUDOPHAKIC CYSTOID MACULAR EDEMA TREATMENT (Incidence and severity of ocular adverse events)
研究概览
简要总结
This is an open-label, Phase I/II study evaluating intravitreal ranibizumab (R) vs. intravitreal Triesence (triamcinolone acetonide) (T) in subjects with acute pseudophakic cystoid macular edema (CME). Twenty consented patients with acute CME after phacoemulsification cataract surgery with posterior chamber intraocular lens implantation (PE/PCIOL) will be randomized 1:1 to treatment with R or T. R patients will receive three monthly R injections, followed by PRN dosing. T patients will receive PRN injections every 3 months. Clinical CME is defined as clinically evident CME, with visual acuity (VA) typically in the 20/40 to 20/200 range. Re-treatment criteria will include clinically evident worsening of CME, combined with any of the following:
- Any increase in spectral domain ocular coherence tomography (OCT) central macular thickness (CMT)
- Any observable fluid on OCT
- Any qualitatively increased perifoveal leakage/pooling on fluorescein angiography (FA).
Patients will be followed monthly through 12 months.
详细描述
- BACKGROUND
1.1 PATHOPHYSIOLOGY
Despite improved cataract surgery instrumentation and techniques, the incidence of clinical CME remains 1 - 3% following uncomplicated PE/PCIOL. CME remains the most common cause of suboptimal post-operative visual acuity (VA) after uncomplicated PE/PCIOL. 1% clinical CME incidence represents 30,000 new cases annually in the USA. Clinical CME is defined as clinically evident CME, with VA typically 20/40 - 20/200. Diagnostic testing can confirm CME by FA leakage and increased CRT on OCT. If left untreated, chronic photoreceptor degeneration and irreversible VA loss can occur, even if the macular edema was to eventually resolve.
1.2 TREATMENT OF PSEUDOPHAKIC CYSTOID MACULAR EDEMA Several treatment options for CME have been investigated, including topical, oral, periocular and intravitreal corticosteroids. Corticosteroids inhibit phospholipase A2, inhibiting production of arachidonic acid, precursor of the lipo-oxyenase (LOX) and cyclo-oxygenase (COX) pathways. Because corticosteroids inhibit both the LOX and COX pathways, corticosteroids may be expected to be more effective than non-steroidal anti-inflammatory drugs (NSAIDs) in decreasing inflammation. However, corticosteroids have side effects, including the potential for increased intraocular pressure (IOP) in susceptible patients, and require additional treatment for secondary glaucoma. NSAIDs specifically inhibit COX-2, and therefore avoid potential complications of corticosteroids. NSAIDs may be a good option for CME treatment of patients who are known corticosteroid responders. However, corneal stromal melting is a rare but serious potential side-effect of topical NSAIDs.
1.3 RANIBIZUMAB (R) AND PSEUDOPHAKIC CYSTOID MACULAR EDEMA Numerous studies, such as ANCHOR, MARINA, and PIER, have shown that R effectively reduces perifoveal capillary leakage and CMT, when used as treatment for exudative age-related macular degeneration (AMD). BRAVO and CRUISE data have shown similar reduction in perifoveal capillary leakage and CMT when used as treatment for retinal vein occlusions (RVO).
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be eligible if the following criteria are met:
- •Ability to provide written informed consent and comply with study assessments for the full duration of the study
- •Age > 18 years
- •Treatment naive subjects with a history of uncomplicated cataract surgery within 3 months of referral for treatment and a diagnosis of CME secondary to cataract surgery within 1 month of referral for treatment.
- •Best corrected ETDRS VA of 20/40 - 20/
- •Spectral domain OCT central retinal thickness > 300 microns.
排除标准
- •Subjects who meet any of the following criteria will be excluded from this study:
- •Any prior treatment for CME secondary to cataract surgery including but not limited to pre or post-operative corticosteroids, NSAIDS, etc.
- •Subject has significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy
- •Any other additional ocular diseases which could irreversibly compromise the visual acuity of the study eye including anterior ischemic optic neuropathy (AION), age related macular degeneration (AMD), retinal detachment, etc.
- •History of allergy to fluorescein, not amenable to treatment
- •History of glaucoma surgery
- •Active infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye
- •Concurrent use of systemic anti-VEGF agents
- •Have received any other systemic experimental drug within 12 weeks prior to enrollment.
- •Currently being treated for active systemic infection
- •Inability to comply with study or follow-up procedures.
- •Patient has a condition that, in the opinion of the investigator would preclude participation in the study (i.e. chronic alcoholism, drug abuse)
- •Pregnancy (positive pregnancy test) or lactation
- •Pre-menopausal women not using adequate contraception. The following are considered effective means of contraception: surgical sterilization or use of oral contraceptives, barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel, an IUD, or contraceptive hormone implant or patch.
- •Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- •Participation in another simultaneous medical investigation or trial
研究组 & 干预措施
RANIBIZUMAB
Ranibizumab patients will receive three monthly Ranibizumab 0.5 mg/0.05 mL injections, followed by PRN dosing, as treatment for acute pseudophakic cystoid macular edema.
干预措施: Ranibizumab, (Drug)
TRIAMCINOLONE ACETONIDE
Triamcinolone acetonide patients will receive PRN Triamcinolone acetonide 4 mg/0.1 mL injections, every 3 months, as treatment for acute pseudophakic cystoid macular edema.
干预措施: Triamcinolone acetonide (Drug)
结局指标
主要结局
SAFETY of INTRAVITREAL RANIBIZUMAB VS. TRIAMCINOLONE ACETONIDE FOR ACUTE PSEUDOPHAKIC CYSTOID MACULAR EDEMA TREATMENT (Incidence and severity of ocular adverse events)
时间窗: 12 Months
To assess the safety of intravitreal R and T for the treatment of acute pseudophakic cystoid macular edema by evaluating: * Incidence and severity of ocular adverse events, as identified by eye examination * Incidence and severity of other adverse events, as identified by physical examination, subject reporting, and changes in vital signs
次要结局
- Proportion of patients with 3 line or better ETDRS letter improvement (%)(12 Months)
- Mean IOP (mm Hg)(12 Months)
- Mean change in spectral domain OCT CMT from baseline (microns)(12 Months)
- Time to 3 line ETDRS letter improvement (days)(12 Months)
- Mean number of R or T injections (#)(12 Months)
- Mean change in ETDRS letters from baseline (letters)(12 Months)