Micropulse Laser for Geographic Atrophy

Watumiaji waliosajiliwa tu ndio wanaweza kutafsiri nakala

Ingia / Ingia

Kiungo kimehifadhiwa kwenye clipboard

HaliImekamilika

Wadhamini

Institut de la Macula y la Retina

JARIBIO LA KLINIKI: NCT01799564

BioSeek: NCT01799564

Maneno muhimu

Kikemikali

Geographic atrophy (GA) causes the loss of the retinal pigment epithelium (RPE) cells in broad areas of the retina. The application of subthreshold micropulse laser spots in healthy RPE in the vicinity of the area of GA may restore the imbalance in survival factors caused by the disease (ie, the laser may decrease vascular endothelial growth factor and RPE-derived transforming growth factor beta, upregulation of pigment epithelium-derived factor). This may slow or even stop the enlargement of atrophy secondary to GA, and therefore, avoid further vision loss.

Tarehe

Imethibitishwa Mwisho:	08/31/2019
Iliyowasilishwa Kwanza:	02/24/2013
Uandikishaji uliokadiriwa Uliwasilishwa:	02/24/2013
Iliyotumwa Kwanza:	02/26/2013
Sasisho la Mwisho Liliwasilishwa:	09/15/2019
Sasisho la Mwisho Lilichapishwa:	09/17/2019
Tarehe halisi ya kuanza kwa masomo:	07/31/2012
Tarehe ya Kukamilisha Msingi iliyokadiriwa:	11/26/2013
Tarehe ya Kukamilisha Utafiti:	11/26/2013

Hali au ugonjwa

Geographic Atrophy

Age-related Macular Degeneration

Uingiliaji / matibabu

Procedure: Micropulse

Awamu

Vikundi vya Arm

Mkono	Uingiliaji / matibabu
Experimental: Micropulse Micropulse laser will be applied to the inferior hemiretina next to the area of atrophy in a randomly selected eye in 1, 2 or 3 occasions	Procedure: Micropulse Between 1 and 3 sessions of micropulse laser will be applied in the inferior hemiretina of the randomly selected eye
No Intervention: Control The fellow eye does not receive any treatment

Vigezo vya Kustahiki

Zama zinazostahiki Kujifunza	50 Years Kwa 50 Years
Jinsia Inastahiki Kujifunza	All
Hupokea Wajitolea wa Afya	Ndio
Vigezo	Inclusion Criteria: - GA > 0.5 disk areas secondary to AMD in both eyes - 50 years or older - The periphery of the atrophic lesions must demonstrate increased autofluorescence - Best corrected visual acuity between 20/20 and 20/400 inclusive - Clear ocular media - Ability to provide informed consent and attend all study visits Exclusion Criteria: - GA secondary to other causes aside from AMD - Evidence of choroidal neovascularization in either eye - Any prior treatment for AMD, aside from antioxidants - Any other ocular condition that would progress in the study period and confound visual acuity assessment - Any ocular or systemic medication known to be toxic to the lens, retina or optic nerve - Presence of idiopathic or autoimmune-associated uveitis - Any intraocular surgery 3 months of entry - Any prior thermal laser in the macula - History of vitrectomy, filtering surgery, corneal transplant or retinal detachment surgery - Previous therapeutic radiation in the ocular region in either eye - Any treatment with an investigational agent in the previous 60 days before study entry

Matokeo

Hatua za Matokeo ya Msingi

1. Change in area of atrophy as measured with fundus autofluorescence (FAF) [Change in area from baseline to week 48]

Difference in baseline area of atrophy as measured with FAF at week 48