DRKS00023860尚未招募不适用
Investigation of genetic and non-genetic biomarkers in the aqueous humor of the eye in various diseases of the eye (age-related macular degeneration, diabetic macular edema and glaucoma) in comparison with controls.
Zentrum für Augenheilkunde Uniklinik Köln0 个研究点目标入组 300 人开始时间: 2020年12月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •For participants with wet AMD or DME, only one eye can be selected as the study eye. The study eye is the eye dedicated to the anti-VEGF injection. If both eyes are treated with anti-VEGF, the study eye with the shortest anti-VEGF treatment history will be (if otherwise the same, the right eye is the study eye).
- •Participants can only participate in the study if all of the following criteria are met:
- •All participants (cataract, glaucoma, wetAMD and DME):
- •1. Written declaration of consent and compliance with the study protocol in accordance with the International Conference on Harmonization (ICH) and local regulations. Alternatively, a legally authorized representative must be able to give the patient's consent in accordance with ICH and local regulations.
- •2. Participants for whom a sampling of> 90 µl aqueous humor appears feasible and safe in the opinion of the examiner
- •Participants with cataracts:
- •1. Male and female participants aged 45 and over with age-related cataracts
- •2. The participant's study eye is intended for cataract surgery
- •Participants with glaucoma:
- •1. Male and female participants aged 18 and over with a diagnosed glaucoma
- •2. The participant's study eye is intended for intraocular cataract or glaucoma surgery (no laser surgery)
- •3. Presence of chronic open-angle glaucoma, pigment dispersion or pseudoexfoliation glaucoma
- •Participants with wetAMD and DME:
- •1. Male and female participants aged = 18 years for DME participants and = 50 years for wetAMD participants
- •2. Clear eye media and adequate pupillary dilatation to enable high quality retinal imaging
- •3. Diagnosis of DME or wetAMD in the study eye
- •4. Therapy-naive patients or patients undergoing treatment with anti-VEGF (aflibercept, ranibizumab or bevacizumab)
- •5. For DME: Type 1 or Type 2 DM as defined by the World Health Organization and / or the American Diabetes Association
- •6. The participant's study eye is intended for an anti-VEGF IVT injection
排除标准
- •Participants will be excluded from the study if any of the following criteria are met:
- •Ocular diseases (all participants):
- •1. Eye history of retinal (focal, pan- or macular) laser photocoagulation within the last three months in the study eye (for AMD: Participants with a history of central macular laser photocoagulation in the study eye are not permitted)
- •2. History of a laser iridotomy or YAG laser capsulotomy within the last month in the study eye
- •3. History of vitreoretinal surgery / pars plana vitrectomy in the study eye
- •4. Neovascularization of the iris in the examination eye
- •5. Participants with a systemic autoimmune disease
- •Previous / accompanying therapy (all participants):
- •1. Any treatment of diseases of the dry eye in the last month before the aqueous humor (AH) sampling (except for the lubrication of eye drops and ointments) in the examination eye
- •2. Any treatment with intraocular or periocular steroids within the last 6 months prior to the AH sampling in the examination eye
- •3. Chronic (> 5 days) topical treatment with steroids within the last week before the sampling in the examination eye
- •4. Systemic use of corticosteroids (oral, intramuscular, intravenous) for> 3 days within the last week before AH sampling
- •5. Current or previous (within 3 months prior to AH sampling) treatment with systemic anti-VEGF
- •Cataract participants (applicable to study eye):
- •1. Any current or previous eye disease other than cataract that may skew the assessment of the retina or affect vision (i.e. AMD, DME, uveitis, history of vein occlusions). Non-proliferative diabetic retinopathy allowed
- •2. Any current or previous intraocular inflammation
- •3. Cataract for reasons other than age-related (i.e. traumatic, secondary, or syndromic).
- •4. Presence of glaucoma
- •Glaucoma participants (applicable to study eye):
- •1. Any current or previous eye disease other than glaucoma and cataract that may skew the assessment of the retina or affect vision (i.e. AMD, DME, uveitis, history of vein occlusions). Non-proliferative diabetic retinopathy is acceptable.
- •2. Any current or previous intraocular inflammation
- •Participants with nAMD or DME (applicable for study eyes):
- •1. All current or previous eye diseases, except nAMD or DME, which falsify the assessment of the macula or can impair vision in the examination eye (e.g. uveitis)
- •2. DME patients with proliferative diabetic retinopathy
- •3. AMD patients with a history of photocoagulation with central macular laser
- •4. Uncontrolled glaucoma or ocular hypertension = 25 mmHg in the examination eye
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