A Phase II Clinical Trial on the Use of ARA 290 for the Treatment of Diabetic Macular Oedema
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Primary Outcome - Best corrected distance visual acuity.
研究概览
简要总结
ARA 290-DMO is a prospective, open label, interventional, single centre, investigator led, phase II trial to examine the effect of ARA 290 on diabetic macular oedema in patients with type 1 or 2 diabetes.
The aim or primary objective of the study was to determine whether ARA 290 administered at a daily dose of 4mg subcutaneously for 12 weeks to patients with diabetes mellitus (DM) and DMO would have a beneficial effect on mean change in best corrected visual acuity (BCVA) from baseline values to week 12.
详细描述
Diabetic retinopathy a very most common cause of sight loss in people of working age. Sight loss occurs in diabetes because of diabetic macular oedema (DMO) and/or proliferative diabetic retinopathy (PDR), both are complications of diabetes in the eye.
In DMO fluid accumulates in the macula, the area responsible for our central sight. As the fluid accumulates the sight drops. The current treatments for DMO include laser and anti VEGF drugs and steroids. Anti VEGF drugs have been very helpful in the treatment of DMO. However, anti VEGF drugs need to be given by an injection into the eye, an Ophthalmologist (eye specialist) or a specialist nurse (a nurse trained for this purpose) will need to deliver this treatment to patients with DMO in the hospital.
Furthermore, patients require injections every four weeks during the first months of treatment and long term treatment is required. Moreover, not all patients respond to anti VEGFs: In 40% of patients the sight may not improve despite these injections. Because many patients with DMO have DMO in both eyes, injections need to be given in both eyes to many patients.
Given the above facts there appeared a clear need to develop new treatments for people with DMO. ARA 290 is a drug that has marked anti-inflammatory properties and has an effect in preventing the death of cells. As inflammation is known to play a role in the occurrence of DMO, it was thought that ARA 290 could potentially be helpful in treating patients with this condition. In light of this, the Investigators carried out this study to find out if ARA 290 was effective in drying the fluid in DMO. If this treatment was successful, benefits may have included a reduction of the demands on health care services and patient benefits of: self administration of the drug at home by the patients; a reduction in hospital visits; treatment of both eyes at once, reduced risks associated with injections; a more pleasant treatment (subcutaneous injection versus an injection into the eye).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •Patients with DR and centre involving DMO with a central subfield thickness of > 400 microns, as determined using SD-OCT;
- •>= 18 years of age
- •Clear media and naïve to previous treatments for DMO.
排除标准
- •Macular oedema related to other retinal disease
- •Hazy media that prevents adequate retinal imaging
- •Allergy to fluorescein
- •Previous treatments for DMO
- •DMO with central subfield thickness of < 400 microns
- •Patients on systemic or topical steroids
- •Use of erythropoiesis stimulating agents within the two months prior to screening or during the trial
- •Treated with any other investigational medication or device within 60 days
- •Pregnant women, women who have not yet reached the menopause (no menses for 12 months or more without an alternative medical cause) who test positive for pregnancy or who are unwilling to take a pregnancy test prior to trial entry or are unwilling to undertake adequate precautions to prevent pregnancy for the duration of the trial.
- •Men who have a female partner and who are unwilling to undertake adequate precautions to prevent pregnancy for the duration of the trial.
- •Female patients who are breastfeeding
- •Active proliferative diabetic retinopathy (PDR) requiring treatment.
- •Patients with other eye diseases besides DR
- •Patients who are unable or unwilling to commit to the study schedule of events
- •Serious illness that is likely to affect the patient's ability to complete the study
- •Any patient showing a clinically significant improvement between the initial screening and presenting for the first screening/baseline visit may no longer be eligible for the study and will be recorded as a screen failure and will not be entered on to the study.
研究组 & 干预措施
Intervention
Subcutaneous daily injection of ARA 290 at a dose of 4mg for 12 weeks.
干预措施: ARA290 (Drug)
结局指标
主要结局
Primary Outcome - Best corrected distance visual acuity.
时间窗: From baseline to week 12 (+/- 7 days)
Best corrected distance visual acuity will be obtained in both eyes by a trained optometrist using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts at baseline and at week 12. The EDTRS total score will be recorded and used for the analysis.
次要结局
- Secondary Outcome - Retinal perfusion(Changes from baseline to week 12 (+/- 7 days))
- Secondary Outcome - Central subfield thickness(Changes from baseline to week 12 (+/- 7 days).)
- Secondary Outcome - Central retinal sensitivity(Changes from baseline to week 12 (+/- 7 days))
- Secondary Outcome - Tear production(Changes from baseline to week 12 (+/- 7 days))
- Secondary Outcome - Patient reported outcome(Changes from baseline to week 12 (+/- 7 days))
- Secondary Outcome - Change in inflammatory markers(Changes from baseline to week 12 (+/- 7 days))
- Secondary Outcome - Number of Adverse events(Changes from baseline to week 12 (+/- 7 days))
- Secondary Outcome -% of participants with ≥ 15 ETDRS letter gain(baseline to week 12)
- Secondary Outcome -% of participants with ≥ 10 ETDRS letter gain(baseline to week 12)
- Secondary Outcome - Patient reported outcomes(Changes from baseline to week 12 (+/- 7 days))
- Secondary Outcome - Change in glycosylated albumin(Changes from baseline to week 12 (+/- 7 days))
- Secondary Outcome - Change in carbamylated albumin(Changes from baseline to week 12 (+/- 7 days))