COMPARISON OF INTRAVITREAL AFLIBERCEPT VS DEXAMETHASONE IMPLANT IN TREATMENT- NAIVE DIABETIC MACULAR EDEMA: A RANDOMIZED CONTROLLED TRIAL’
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the efficacy of intravitreal Aflibercept and intravitreal Dexamethasone implant in improving best-corrected visual acuity (BCVA) in treatment-naive DME patients
研究概览
简要总结
Diabetic macular edema (DME) is a leading cause of vision loss in patients with diabetic retinopathy. The pathophysiology of DME involves multiple mechanisms, including vascular endothelial growth factor (VEGF) overexpression and chronic inflammation. Two major pharmacologic approaches are widely used for DME management:
Anti-VEGF Therapy (Aflibercept)
Aflibercept is a recombinant fusion protein that binds VEGF-A, VEGF-B, and placental growth factor (PlGF), thereby inhibiting neovascularization and vascular leakage.
It has been established as a first-line therapy for center-involving DME due to its proven efficacy in improving visual acuity (BCVA) and reducing central macular thickness (CMT).
However, frequent injections (every 4-8 weeks) are required to maintain efficacy, leading to increased treatment burden and patient non-compliance.
2 Corticosteroid Therapy (Dexamethasone Implant - Ozurdex)
The dexamethasone intravitreal implant (Ozurdex) provides sustained-release corticosteroid therapy, targeting the inflammatory component of DME. It reduces cytokine-mediated vascular permeability and stabilizes the blood- retinal barrier. Compared to anti-VEGF agents, Ozurdex has a longer duration of action, potentially reducing the number of injections required .However, side effects such as intraocular pressure (IOP) elevation and cataract progression are concerns, especially in phakic patients.
In DME, intravitreal corticosteroids, been traditionally used as second-line treatment, due to the risk of intraocular pressure increase and cataract-related adverse events.
However, attention has recently been focused on the primary or early use of intravitreal corticosteroids, due to growing evidence of the crucial role of inflammation in the pathogenesis of DME.
Furthermore, intravitreal steroid implants offer the additional advantage of a longer duration of action compared to anti-vascular endothelial growth factor agents (anti-VEGF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Double
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion Criteria- Male and female patients more than 18 years old with visual impairment due to naive-DME.
- •Patients with type 1 or type 2 diabetes mellitus and HbA1c of less than 10 percentage at screening Baseline CST more than 300 µm on spectral-domain OCT.
- •BCVA between 20/40(6/12) and 20/320(6/96) (ETDRS letters 70 to 25).
- •Hemoglobin A1c less than 10 percentage Patient or legally acceptable representative (LAR) willing to voluntarily provide signed informed consent for participation in the study.
排除标准
- •Exclusion criteria Patients with HbA1C more than 10 mg percentage or those who did not have stable control of diabetes since the last 3 months.
- •Patients with a history of vitrectomy, cataract leading to poor imaging, intra-ocular surgery within 3 months of enrollment into the study, aphakia, epiretinal membrane, vitreomacular traction.
- •Patient with uncontrolled hypertension (defined as a systolic blood pressure more than 160 mm Hg or a diastolic blood pressure more than 95 mm Hg) Patient with history of cerebrovascular accident or myocardial infarction within 6 months, renal failure requiring dialysis or renal transplant, or other retinal vascular diseases Patient with existing or suspected ocular or periocular infection in the study eye.
- •Patient with an existing intraocular inflammation (IOI).
- •Patient with uncontrolled glaucoma (defined as intraocular pressure more than 25 mmHg despite treatment with anti-glaucoma medication,) or according to Investigator’s judgment.
- •Previous treatment with any anti-VEGF drugs or investigational drugs in the study eye Use of dexamethasone intravitreal implant (Ozurdex) or fluocinolone acetonide intravitreal implant (Iluvien) in study eye at any time.
- •Laser photocoagulation (focal/grid or pan retinal) in the study eye during the 3-month period prior to baseline Intraocular surgery including YAG laser in the study eye during the 3-month period prior to baseline Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive HCG pregnancy test Structural damage of the fovea in the study eye at screening likely to preclude improvement in visual acuity following the resolution of macular edema, including atrophy of the retinal pigment epithelium, subretinal fibrosis, laser scar(s), epiretinal membrane involving fovea or organized hard exudate plaques Proliferative diabetic retinopathy requiring Pan retinal photocoagulation (PRP).
结局指标
主要结局
To compare the efficacy of intravitreal Aflibercept and intravitreal Dexamethasone implant in improving best-corrected visual acuity (BCVA) in treatment-naive DME patients
时间窗: Post Operative day-1,04TH WEEK,08TH WEEK,12TH WEEK THAN ONCE IN MONTH UP TO 06 MONTH
次要结局
- a)Safety profile (adverse events, intraocular pressure rise, cataract progression).
研究者
DR KAUSHALENDRA SINGH
COMMAND HOSPITAL ,EASTERN COMMMAND ,KOLKATA