Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000167
Status:
COMPLETED
Last Update Posted:
2010-03-24
First Post:
1999-09-23
Brief Title:
Complications of Age-Related Macular Degeneration Prevention Trial
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
Complications of Age-Related Macular Degeneration Prevention Trial CAPT
Status:
COMPLETED
Status Verified Date:
2007-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPT
Brief Summary:
To determine whether application of low-intensity laser treatment of eyes with drusen in the macula can prevent later complications of age-related macular degeneration and thereby preserve visual function
Detailed Description:
Complications of age-related macular degeneration AMD are the leading cause of severe vision loss among people aged 65 and over in the United States and many Western countries Most approximately 90 percent of this vision loss is due to the neovascular or wet form of AMD The word neovascular describes the development of new abnormal blood vessels in the back of the eye Unfortunately the majority of these new vessels are not amenable to currently available treatments
The first sign that an eye may develop AMD is the presence of drusen yellowish deposits under the retina Current data suggests that eyes with large drusen are at increased risk for developing the vision threatening complications of AMD Since the 1970s investigators have reported consistently that laser photocoagulation causes a reduction in large drusen However results of the effects of laser treatment on preventing later complications of AMD have been less consistent and based on relatively small numbers of patients
Further study into the ability of a treatment to prevent vision loss from the advanced forms of AMD would have profound public health implications A treatment that could reduce the risk of developing neovascularization by 30 percent might reduce the risk of blindness from AMD by one half The Complications of Age-related Macular Degeneration Prevention Trial CAPT will assess whether treating drusen by laser photocoagulation reduces the risk of loss of visual acuity
The CAPT is a multi-center prospective randomized clinical trial designed to assess the safety and effectiveness of low-intensity laser treatment in preventing vision loss among patients with large drusen in both eyes A total of 1052 participants were enrolled in the study Participants had one eye randomly assigned to laser treatment performed by a CAPT-certified ophthalmologist The other eye was not treated Both eyes were observed carefully for any changes for a period of five years The effectiveness of the treatment was assessed using the following criteria
Change in visual acuity primary outcome measure of the study
Incidence of complications of AMD such as neovascularization serous detachment of the pigment epithelium and geographic atrophy
Changes in contrast threshold and critical print size for reading
Quality of life assessments for patients using the Visual Function Questionnaire 25 VFQ-25 were conducted at the time of enrollment and at 5 years
STUDY RESULTS
Follow-up of patients was excellent less than 3 of visual acuity examinations were missed At 5 years 188 205 treated eyes and 188 205 observed eyes had visual acuity scores 3 lines worse than at the initial visit p 100 The cumulative 5-year incidence rates for treated and observed eyes for CNV were 133 and 133 p095 respectively and for GA were 74 and 78 p064 respectively The contrast threshold doubled in 239 of treated eyes and in 205 of observed eyes p040 The critical print size doubled in 296 of treated eyes and in 284 of observed eyes p070 Seven 07 treated eyes and 14 13 observed eyes had an adverse event of a 6 -line loss in visual acuity in the absence of late age-related macular degeneration or cataract
As applied in CAPT low intensity laser treatment did not demonstrate a clinically significant benefit on vision in eyes of people with bilateral large drusen
The first sign that an eye may develop AMD is the presence of drusen yellowish deposits under the retina Current data suggests that eyes with large drusen are at increased risk for developing the vision threatening complications of AMD Since the 1970s investigators have reported consistently that laser photocoagulation causes a reduction in large drusen However results of the effects of laser treatment on preventing later complications of AMD have been less consistent and based on relatively small numbers of patients
Further study into the ability of a treatment to prevent vision loss from the advanced forms of AMD would have profound public health implications A treatment that could reduce the risk of developing neovascularization by 30 percent might reduce the risk of blindness from AMD by one half The Complications of Age-related Macular Degeneration Prevention Trial CAPT will assess whether treating drusen by laser photocoagulation reduces the risk of loss of visual acuity
The CAPT is a multi-center prospective randomized clinical trial designed to assess the safety and effectiveness of low-intensity laser treatment in preventing vision loss among patients with large drusen in both eyes A total of 1052 participants were enrolled in the study Participants had one eye randomly assigned to laser treatment performed by a CAPT-certified ophthalmologist The other eye was not treated Both eyes were observed carefully for any changes for a period of five years The effectiveness of the treatment was assessed using the following criteria
Change in visual acuity primary outcome measure of the study
Incidence of complications of AMD such as neovascularization serous detachment of the pigment epithelium and geographic atrophy
Changes in contrast threshold and critical print size for reading
Quality of life assessments for patients using the Visual Function Questionnaire 25 VFQ-25 were conducted at the time of enrollment and at 5 years
STUDY RESULTS
Follow-up of patients was excellent less than 3 of visual acuity examinations were missed At 5 years 188 205 treated eyes and 188 205 observed eyes had visual acuity scores 3 lines worse than at the initial visit p 100 The cumulative 5-year incidence rates for treated and observed eyes for CNV were 133 and 133 p095 respectively and for GA were 74 and 78 p064 respectively The contrast threshold doubled in 239 of treated eyes and in 205 of observed eyes p040 The critical print size doubled in 296 of treated eyes and in 284 of observed eyes p070 Seven 07 treated eyes and 14 13 observed eyes had an adverse event of a 6 -line loss in visual acuity in the absence of late age-related macular degeneration or cataract
As applied in CAPT low intensity laser treatment did not demonstrate a clinically significant benefit on vision in eyes of people with bilateral large drusen
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None