New Pattern of Retinal Laser Treatment for PDR

Официальное название

A Prospective Study on a New Pattern of Retinal Laser Treatment for Proliferative Diabetic Retinopathy (PDR)

Обзор

The objective of the study is to evaluate the efficacy of a new pattern of argon-laser in treating patients with proliferative diabetic retinopathy (PDR).

Подробное описание

Argon-laser pan retinal photocoagulation (PRP) is the first-line therapy for proliferative diabetic retinopathy (PDR) nowadays, which is believed to function by reducing retinal ischemia and decreasing the stimulation for neovascularization. However, diabetic retinopathy (DR) would still progress uncontrollably even after PRP, and PRP would result in reduction in visual acuity and loss of peripheral visual field, which may be influenced by the distribution pattern of the retinal laser treatment.

A variety of modified argon-laser patterns have been reported - a more central PRP, a more peripheral PRP, a central-sparing PRP or an extended-targeted PRP, yet the risk of developing neovascularization is higher in retina around the posterior vascular arcades and alongside the major retinal vessels.

This study will include 300 patients with PDR, who will be treated with a new pattern of argon-laser. An initial retinal laser would be given in the posterior retina outside the arcades and the mid-peripheral retina flanking the large vessels. Then investigators will conduct no less than 2 years follow-up. Further peripheral PRP and anti-VEGF administration would be added only if neovascularization progress, aiming to stop DR progression with the minimum of laser energy.

Вмешательства

• Процедура A new pattern of retinal laser
  A new pattern of retinal argon laser combines anti VEGF treatment within 2 weeks. Spot argon-laser photocoagulation was started 1 disc-diameter nasal to the optic disc, outside the superior and inferior vascular arcades, and 2 disc diameter (DD) temporal to the fovea, and the mid-peripheral retina flanking the large vessels. Further peripheral PRP and anti-VEGF administration would be added only if neovascularization progress.

Первичные конечные точки

• BCVA [Срок оценки: From enrollment to the end of the 2-year follow-up period. (at enrollment; 1 month, 3months, 6 months, 1 year and 2 years after the initial laser treatment)]
• CMT [Срок оценки: From enrollment to the end of the 2-year follow-up period. (at enrollment; 1 month, 3months, 6 months, 1 year and 2 years after the initial laser treatment)]
• Mean VF loss [Срок оценки: 1 year and 2 years after the initial laser treatment during the follow-up period.]
• Further treatment [Срок оценки: From enrollment to the end of the 2-year follow-up period.]

Критерии участия

Критерии включения

• Having given free and informed consent to take part in the study.
• Diabetes mellitus (DM) under stable treatment during the study, aged 18y to 70y, with no significant underlying systemic diseases (such as impaired renal function, severe cardiac disease, etc.);
• Clinically diagnosed PDR, with the presence of neovascularization confirmed by ultra-widefield fundus photography and widefield OCT angiography.

Критерии исключения

• Previous treatment with PRP;
• Previous treatment with anti-VEGF agents or corticosteroids within 3 months;

2\. Severe cataract, massive vitreous hemorrhage, or extensive preretinal hemorrhage that makes pan retinal photocoagulation impossible; 3. Unable to tolerate argon-laser retinal treatment.; 4. Vitreous macular traction or traction retinal detachment need to be performed with vitrectomy; 5. Retinal vascular occlusion, age-related macular degeneration, retinal angioma, uveitis, glaucoma, optic neuropathy, or other ocular diseases that can lead to vitreous hemorrhage and/or neovascularization; 6. Other conditions that the researcher found improper to be included into this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Eye and ENT Hospital of Fudan University — Шанхай

Идентификаторы

NCT: NCT07315802 · Retinal Laser for PDR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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