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临床试验/NCT05976139
NCT05976139招募中不适用

Treatment of Macular Oedema in Patients with Hereditary Retinal Dystrophies by Applying the Micropulsed Subthreshold Laser

Fondazione G.B. Bietti, IRCCS2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年9月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10
试验地点
2
主要终点
assessment of significative change in retinal oedema compared to baseline

研究概览

简要总结

The purpose of this study is to investigate whether subthreshold treatment with micropulsed laser can be effective in resolving macular edema in patients with inherited retinal dystrophy.

Visits will be performed after 1, 3, 6, 9, 12, 18, and 24 months after treatment. Laser treatment will be performed on the day of the first visit, and its repetition at subsequent visits between months 3 and 12 will be evaluated.

Evaluations of treatment effects will include:

  • comprehensive ophthalmologic examination
  • multifocal electroretinogram
  • OCT examination
  • OCT-angiography examination
  • retinography

Primary endpoint.

  • central retinal thickness, measured by OCT

详细描述

BACKGROUND:

Degenerative diseases of the visual system classified as rare and, in particular, those affecting the retina (known as Inherited retinal dystrophies, IRDs) cause very severe functional deficits. Their onset is in many cases particularly early with a consequent visual impact of extreme severity. They constitute a heterogeneous group from a clinical point of view, but in all of them the loss of photoreceptors causes progressive vision loss that can result in complete blindness.

These pathologies can be complicated by the presence of cataracts, epiretinal membrane and macular oedema (10-50%), resulting in a worsening of visual acuity. While surgical treatment is applicable for the first two complications, the treatment of macular oedema can make use of several options. Oral or topical diuretics (Acetazolamide) are still the first therapeutic approach and, if oedema persists despite treatment, intravitreal corticosteroid injection has been used in various reports. The injection of anti-Vascular Endothelial Growth Factor (VEGF) drugs and vitrectomy have also been proposed but with conflicting results. The use of topical non-steroidal drugs has been studied and proven to be valuable, although inferior to diuretic treatment in terms of visual recovery. The use of intravitreal corticosteroids is also not without possible further complications such as ocular hypertension and early onset of cataracts.

Despite some improvement in retinal oedema by taking the above-mentioned diuretics, relapses can be observed at the end of therapy, reason for taking longer periods (>12 weeks) of therapy. However, the same chronic continuation of diuretic therapy is not always desirable considering its possible adverse events such as tingling sensation, malaise, altered taste sensation and gastrointestinal disorders.

RATIONALE:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Sequential
主要目的
Treatment
盲法
None

盲法说明

no masking

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with inherited retinal disease
  • Age between 18 and 80 years
  • Conclusive molecular genetic study for IRD
  • Male or female patient
  • Presence of macular oedema assessed by sd-OCT with reduction ≤ 20% after 3 months of diuretics or draining supplements or 4 months after last anti-VEGF or steroid injection
  • Phakic and pseudophakic patients
  • Central Retinal thickness > 320 microns in men and > 305 microns in women
  • Informed consent freely granted and acquired before the start of the study
  • Participant has the ability to understand and willingness to follow study instructions and is likely to complete all required visits and procedures.

排除标准

  • Patients with cataract extraction prior to 6 months
  • Patients with IOP ≥ 20 mmHg
  • Patients with a clinical diagnosis of retinal dystrophy of unproven genetic origin
  • Patients with diabetes
  • Patients with central serous chorioretinosis, retinal vein occlusion, age-related degeneration
  • Patients with current or previous vitreo-retinal pathology or with indication for vitreo-retinal surgical therapy (tractional oedema)
  • Patients with a lack of target fixation at 32 cm
  • Pregnant women

结局指标

主要结局

assessment of significative change in retinal oedema compared to baseline

时间窗: up to 24 months

assessment of central retinal thickness by macular SD-OCT

次要结局

  • To study the retinal function in the macular area before and after treatment.(up to 24 months)
  • To study the retinal perfusion of the macular area by OCT-angiography before and after treatment.(up to 24 months)
  • To study changes in visual acuity between before and after treatment(up to 24 months)

研究者

发起方
Fondazione G.B. Bietti, IRCCS
申办方类型
Other
责任方
Principal Investigator
主要研究者

lucia ziccardi

Principal Investigator

Fondazione G.B. Bietti, IRCCS

研究点 (2)

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