Age-related Macular Degeneration Clinical Trial
Official title:
Selective Retinal Pigment Epithelium Laser Therapy (SRT) for Macular Disease of the Retina
Laser photocoagulation of the retina targeting the outer layers is an established therapy for proliferative retinopathy and macular edema from diabetic microangiopathy or retinal vein occlusion, centrals serous retinopathy, and extrafoveal subretinal neovascular membranes. However, collateral damage occurs and scotomas can result when using conventional lasers with pulse duration of 100ms and more. This is particularly relevant for laser treatments of the macula where the main therapeutic effect results from stimulation of the retinal pigment epithelium cells and photoreceptor damage is thought to be an unnecessary side effect. Recent experimental research with new laser devices using much shorter pulse duration has shown that photoreceptor damage can be greatly reduced and the retinal pigment epithelium selectively targeted, hence the term selective retinal pigment epithelium laser therapy (SRT). Investigators hypothesize that SRT is equally effective as standard laser photocoagulation for macular disease but minimizes local visual field defects. In this study, patients with central serous retinopathy, macular edema from diabetic microangiopathy or branch vein occlusion, and non-exudative age-related macular degeneration will be treated with SRT. Patients will be assessed 1, 3 and 6 months after treatment.
Background Laser photocoagulation of the retina targeting the outer layers is an established therapy for proliferative retinopathy and macular edema from diabetic microangiopathy or retinal vein occlusion, centrals serous retinopathy, and extrafoveal subretinal neovascular membranes. However, collateral damage occurs and scotomas can result when using conventional lasers with pulse duration of 100ms and more. This is particularly relevant for laser treatments of the macula where the main therapeutic effect results from stimulation of the retinal pigment epithelium cells and photoreceptor damage is thought to be an unnecessary side effect. Recent experimental research with new laser devices using much shorter pulse duration has shown that photoreceptor damage can be greatly reduced and the retinal pigment epithelium selectively targeted, hence the term selective retinal pigment epithelium laser therapy (SRT). In age-related macular degeneration, regression of drusen has been observed after laser treatment with convention laser or SRT. Investigators hypothesize that SRT is equally effective as standard laser photocoagulation for macular disease but minimizes local visual field defects. Objective To assess the efficacy of SRT in patients with central serous retinopathy, macular edema from diabetic microangiopathy or branch vein occlusion, and non-exudative age-related macular degeneration. Up to five patients with proliferative diabetic retinopathy can optionally be treated with SRT too. Methods At baseline and during follow-up patients will receive a full ophthalmic examination including optical coherence tomography, fundus autofluorescence imaging, fluorescein angiography (FA), and visual acuity testing. SRT (R:GEN Laser System by Lutronic Corporation, Korea) will be delivered under topical anesthesia. For titration of energy spots will first be applied outside the major arcades. Immediately thereafter FA will be performed for extrapolation of the laser dose, since the treatment is sub-threshold and laser spots will not be visible biomicroscopically. The patient will then be treated at the discretion of the ophthalmologist with up to 500 laser burns. One hour after the laser treatment FA will be repeated to confirm the treatment effect. Patients will be assessed 1, 3 and 6 months after treatment. Pulse duration can be chosen between 200ns and 2μs. The maximum pulse energy will be 1mJ. 1-30 pulses will be applied for every laser burn at a frequency of 100Hz. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05984927 -
NG101 AAV Gene Therapy in Subjects With Wet Age-Related Macular Degeneration
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT05536297 -
Avacincaptad Pegol Open-Label Extension for Patients With Geographic Atrophy
|
Phase 3 | |
Recruiting |
NCT04101604 -
Biomarkers of Common Eye Diseases
|
||
Completed |
NCT04005352 -
Study to Assess the Efficacy and Safety of Brolucizumab 6mg Compared to Aflibercept 2 mg in a Treat-to-control Regimen (TALON)
|
Phase 3 | |
Withdrawn |
NCT02873351 -
A Safety and Efficacy Study of Carbidopa-levodopa in Patients With Macular Degeneration
|
Phase 2 | |
Active, not recruiting |
NCT02802657 -
Efficacy and Safety of "Treat-and-Extend" Regimen Versus "Pro Re Nata" of Conbercept in Age-related Macular Degeneration
|
Phase 4 | |
Not yet recruiting |
NCT02864472 -
Comparison of PDT Combination With Ranibizumab vs. Ranibizumab Monotherapy in Persistent PCV With Initial Loading Dose
|
Phase 4 | |
Recruiting |
NCT01521065 -
An Open-label Study to Evaluate the Clinical and Economic Benefits of I-Ray in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
|
Phase 2 | |
Completed |
NCT02035722 -
Intravitreal Injections-related Anxiety
|
Phase 2/Phase 3 | |
Completed |
NCT01445548 -
Sirolimus for Advanced Age-Related Macular Degeneration
|
Phase 1/Phase 2 | |
Completed |
NCT01175395 -
20089 TA+Lucentis Combo Intravitreal Injections for Treatment of Neovascular Age-related Macular Degeneration (AMD)
|
Phase 1/Phase 2 | |
Recruiting |
NCT01048476 -
Effects of Lutein and Zeaxanthin Supplementation on Age-related Macular Degeneration
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT01174407 -
Implication of CD35, CD21 and CD55 in Exudative Age-related Macular Degeneration
|
N/A | |
Terminated |
NCT00712491 -
Phase 1/2 Study of an Ocular Sirolimus (Rapamycin) Formulation in Patients With Age-Related Macular Degeneration
|
Phase 1/Phase 2 | |
Completed |
NCT00345176 -
Age-Related Eye Disease Study 2 (AREDS2)
|
Phase 3 | |
Completed |
NCT02140151 -
Prophylactic Ranibizumab for Exudative Age-related Macular Degeneration
|
Phase 1/Phase 2 | |
Completed |
NCT02555306 -
A Phase I/II Safety, Tolerability, Immunogenicity, and Bioactivity Study of DE-122 Injectable Solution for Refractory Exudative Age-related Macular Degeneration
|
Phase 1/Phase 2 | |
Recruiting |
NCT04796545 -
Post-market Clinical Investigation of the SING IMT System, Model NG SI IMT 3X in Patients With End-stage Age-related Macular Degeneration
|
N/A | |
Completed |
NCT03166202 -
Age-Related Macular Degeneration, Scotopic Dysfunction, and Driving Performance in a Simulator
|
||
Completed |
NCT01397409 -
Evaluation of AGN-150998 in Exudative Age-related Macular Degeneration (AMD)
|
Phase 2 |