ISRCTN16962255已完成2 期
A Phase II Clinical Trial on the use of ARA 290 for the treatment of Diabetic Macular Oedema
Belfast Health & Social Care Trust (UK)0 个研究点目标入组 9 人开始时间: 2015年6月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 9
研究概览
简要总结
2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32674280/ (added 04/07/2024)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Patients with diabetic retinopathy and centre involving DMO with a central subfield thickness of > 400 microns, as determined using SD-OCT
- •2. >= 18 years of age
- •3. Clear media and naïve to previous treatments for DMO
排除标准
- •Exclusion criteria as of 08/12/2016:
- •1. Macular oedema related to other retinal disease
- •2. Hazy media that prevents adequate retinal imaging
- •3. Allergy to fluorescein
- •4. Previous treatments for DMO
- •5. DMO with central subfield thickness of < 400 microns
- •6. Patients on systemic or topical steroids
- •7. Use of erythropoiesis stimulating agents within the two months prior to screening or during the trial
- •8. Treated with any other investigational medication or device within 60 days
- •9. Pregnant women, women who have not yet reached the menopause (no menses for = 12 months 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.
- •10. Men who have a female partner and who are unwilling to undertake adequate precautions to prevent pregnancy for the duration of the trial.
- •11. Female patients who are breastfeeding
- •12. Active proliferative diabetic retinopathy (PDR) requiring treatment.
- •13. Patients with other eye diseases besides DR
- •14. Patients who are unable or unwilling to commit to the study schedule of events
- •15. 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.
- •Original exclusion criteria:
- •1. Macular oedema related to other retinal disease
- •2. Hazy media that prevents adequate retinal imaging
- •3. Allergy to fluorescein
- •4. Previous treatments for DMO
- •5. DMO with central subfield thickness of < 400 microns
- •6. Patients on systemic or topical steroids
- •7. Use of erythropoiesis stimulating agents within the two months prior to screening or during the trial
- •8. Treated with any other investigational medication or device within 60 days
- •9. Pregnant women, women who have not yet reached the menopause (no menses for = 12 months without an alternative medical cause) who test positive for pregnancy, 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.
- •10. Female patients who are breastfeeding
- •11. Active proliferative diabetic retinopathy (PDR) requiring treatment.
- •12. Patients with other eye diseases besides diabetic retinopathy
- •13. Patients who are unable or unwilling to commit to the study schedule of events
- •Any patient showing improvement between the initial screening and presenting for the first screening/baseline visit will no longer be eligible for the study, will be recorded as a screen failure and will not be entered on to the study
研究者
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