Age-related Macular Degeneration (AMD) Clinical Trial
— AMDOfficial title:
Development of New Approaches to Rehabilitating Vision Loss in Veterans With Age-Related Macular Degeneration
This study will help develop new methods of rehabilitating Veterans with vision loss due to Age-related macular degeneration.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | June 30, 2026 |
Est. primary completion date | December 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years and older |
Eligibility | Inclusion Criteria: 1. The subject is a Veteran. 2. The subject is 50 years of age. 3. The subject has best-corrected visual acuity (BCVA) of 20/40 or worse in each eye, as determined by the standard CNVAMC optometric tests. 4. The subject has visual field deficit of 10O in either eye as determined by the Octopus 900 perimetry (Haag-Streit Diagnostics, Haag-Streit USA, Mason, OH) administered by CNVAMC. (When the deficit/s are binocular, they do not necessarily have to be in binocularly corresponding positions.) 5. The subject has received a formal clinical diagnosis of age-related macular degeneration (AMD) in one or both eyes (binocular AMD does not necessarily have to be in binocularly corresponding positions)7,8,56. 6. The subject has visual deficit in either eye (wavy lines and/or missing/darkened areas on the grid) determined by the standard Amsler Grid Test7,8,56. 7. The subject has not yet started any rehabilitative treatment for AMD-related vision loss. 8. Both eyes of the subject are otherwise age-appropriately stable, and neither eye has any other visual defects, as determined by the standard CNVAMC ophthalmological examination. 9. The subject must be able to understand the nature and individual consequences of the study. 10. The subject must be able to provide signed and dated informed consent before start of any participation in the study procedures. 11. Women with childbearing potential must test negative for pregnancy using a standard urine test prior to participating in each functional magnetic resonance imaging (fMRI) procedure. (This exclusion criterion is mandated by the Augusta University Institutional Review Board [AU IRB], which also serves as the IRB of record of the CNVAMC. It is intended as an extra precautionary measure to help ensure the health and safety of this vulnerable population. The proposed study will comply with this requirement.) Exclusion Criteria: 1. According to the patient's VA clinical records, the patient has one or more clinically diagnosed neurological disorder. 2. According to the patient's VA clinical records, the patient has one or more clinically diagnosed cognitive deficits. 3. According to the patient's VA clinical records, the patient has been clinically diagnosed with a psychiatric disorder that would make it unduly uncomfortable or otherwise clinically inadvisable for the subject to participate in the study. 4. According to the patient's VA clinical records, according to the patient, or both, the patient has motor disorder/s that would make it unduly uncomfortable or otherwise clinically inadvisable for the subject to participate in the study. 5. According to the patient's VA clinical records, according to the patient, or both, the patient has an MR-incompatible implant and/or another condition (e.g., claustrophobia) that would make it inadvisable for the subject to participate in MR imaging or any other study procedure. 6. The patient does not understand the informed consent information and/or the standard study instructions in spoken or written English, and/or is unable to follow study instructions. [The purpose of this exclusion criterion, required by the AU IRB, is to help ensure that the subjects adequately understand all the information relevant to providing informed consent, as well as the study instructions.] 7. Inability to give informed consent to participate in the study. 8. Pregnancy, as determined by a standard urine test for pregnancy. 9. Participation in other study/studies including an investigational drug or device during the present study. |
Country | Name | City | State |
---|---|---|---|
United States | Charlie Norwood VA Medical Center, Augusta, GA | Augusta | Georgia |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | Augusta University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of object recognition | This outcome will be measured as the accuracy (% correct) with which the study subjects recognize the text objects before, during and after their participation in the study procedures. | 6-10 weeks | |
Primary | Response of brain regions of interest (ROI) as reflected in the BOLD (blood oxygenation level-dependent) response | This outcome will be measured as changes (if any) of the BOLD responses of brain ROIs before, during and after their participation in the study procedures. | 6-10 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01694680 -
Intervention Trial in Early Age-related Macular Degeneration
|
N/A | |
Completed |
NCT01224847 -
Intravitreal Injection Anesthesia - Comparison of Different Topical Agents
|
N/A | |
Withdrawn |
NCT04697953 -
Efficacy and Safety of Brolucizumab 6mg in a Treat and Extend Regimen in Patients With Neovascular Age-Related Macular Degeneration (nAMD) With Prior Anti-VEGF Exposure (PEREGRINE)
|
Phase 3 | |
Completed |
NCT05037396 -
Evaluation of Number of Patient Eyes That Remained on or Switched to Anti-VEGF Treatment After Initiation of Broluciumab
|
||
Completed |
NCT00647439 -
Genetics and Markers of Degenerative and Inflammatory Eye Diseases
|
||
Terminated |
NCT00902785 -
A Study Of Early Markers Of Choroidal Neovascularization
|
Phase 4 | |
Terminated |
NCT02348359 -
X-82 to Treat Age-related Macular Degeneration
|
Phase 2 | |
Recruiting |
NCT03690505 -
Assessment of the Knowledge and Needs of Patients With AMD Before a Therapeutic Patient Education Program is Put in Place
|
N/A | |
Recruiting |
NCT03577041 -
Medico-economic Evaluation of Anti-VEGF Treatments in the Treatment of naïve Age-related Macular Degeneration (AMD): a Model Adapted to the French Context
|
||
Completed |
NCT05082415 -
Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (IRIS Study)
|
||
Completed |
NCT02445313 -
Measuring Geographic Atrophy in AMD Patients Using the Nidek MP-3 Microperimetry Device
|
||
Recruiting |
NCT00354445 -
A Clinical Trial to Explore the Safety and Efficacy of Injections of Macugen When Given Every 6 Weeks in Subjects With AMD
|
Phase 4 | |
Completed |
NCT05111743 -
Real-world Evaluation of Brolucizumab for the Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD) (Komodo Health)
|
||
Terminated |
NCT02398500 -
Safety Tolerability and Efficacy of Intravitreal LMG324 in the Treatment of Neovascular Age-Related Macular Degeneration
|
Phase 1/Phase 2 | |
Completed |
NCT05146687 -
Real-world Evaluation of Prevalence of Ocular Adverse Events in Patients With Neovascular (Wet) Age-related Macular Degeneration (AMD) Who Received Anti-vascular Endothelial Growth Factor (VEGF) Agents (Komodo Health)
|
||
Completed |
NCT05110209 -
Real-world Evaluation of Prevalence of Ocular Adverse Events in Patients With Neovascular (Wet) Agerelated Macular Degeneration (AMD) Who Received Anti-VEGF Agents (IRIS Registry)
|
||
Recruiting |
NCT04292080 -
Long-Term Analysis of DImethyl Fumarate, to Slow the Growth of Areas of Geographic Atrophy
|
Phase 2 | |
Recruiting |
NCT03859245 -
Photobiomodulation & Ketogenic Diet for Treatment of Mid-periphery Retinal Disorders for Alzheimer's Disease Prevention
|
N/A | |
Completed |
NCT02022540 -
Phase 1 Study of Topical Ocular PAN-90806 for Neovascular AMD
|
Phase 1 | |
Completed |
NCT02585401 -
Evaluation of Physician Knowledge of Safety and Safe Use Information for Aflibercept in Canada
|
N/A |