Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01778491
Other study ID # 130027
Secondary ID 13-EI-0027
Status Completed
Phase
First received January 26, 2013
Last updated April 4, 2018
Start date November 5, 2012
Est. completion date September 29, 2015

Study information

Verified date September 29, 2015
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background:

- Age-related macular degeneration (AMD) is a disease that blurs the sharp vision needed for activities such as reading, sewing, and driving. It affects the macula, the center of the retina at the back of the eye, which allows a person to see fine detail. Researchers want to collect medical histories, eye exam data, and genetic information that may be associated with AMD. They want to compare this information with information collected from people without AMD.

Objectives:

- To collect medical information and gene samples for researchers studying AMD.

Eligibility:

- Individuals between and 60 and 90 years of age who have AMD in at least one eye.

- Individuals between and 60 and 90 years of age who have no AMD in either eye.

Design:

- This study will involve one study visit. This study visit will last 6 to 8 hours.

- Participants will have the following tests and exams as part of their study visit:

- Full physical exam and medical history

- Full eye examination

- Laser scan of the eye

- Retina function test

- Vision sensitivity test

- Optional blood sample (for genetic study)

- No treatment will be provided as part of this study.


Description:

Objective: Late age-related macular degeneration (AMD) is the leading cause of blindness among elderly in the United States. At present the current classification systems do not take into consideration advances in imaging technology and genotyping and phenotyping.

Clinical centers in the US and around the world will conduct a pilot cohort study that will bring together resources and commitment to test the feasibility of developing a new classification scheme for AMD using imaging and visual function biomarkers, with the potential of correlating genetic information obtained in the future. These data could eventually help develop an understanding of the mechanisms involved in the development and progression of AMD. A database of men and women with and without AMD will be established and maintained. The project will recruit participants who have various stages of AMD and controls. The pilot study will identify the feasibility of obtaining imaging and visual function data and help identify which of these modalities should be included in a full scale longitudinal study, as well as how frequently and at which sites they should be obtained. All data, images and any potential biospecimens from the full scale longitudinal study will be available to researchers worldwide to help in the development of biomarker identification and classification development. The initiative should provide an unparalleled state-of-the-art standardized phenotype/genotype including AMD status with information on imaging, visual function, and biospecimen biomarkers. This study is the first phase of this initiative to test the feasibility and logistics of defining a standard database including enhanced phenotype and genotype data.

Study Population: This cohort study will recruit a minimum of 200 total participants with various stages of AMD, including controls and obtain the appropriate images and measures of visual function needed for the investigation and validation of an AMD phenotype.

Design: This cohort study is a multi-national, multi-center, observational study focused on AMD. The study is a pilot to test the ability to create an archive of data, biological samples (collected at other study sites), measures of visual function and ophthalmic images collected over time from a very well clinically characterized population of participants with a diagnosis of AMD. The database will also include a control group consisting of participants without a diagnosis of AMD.

Outcome Measures: The design of this cohort study and the data being collected will allow users to assess phenotypes of AMD, develop and evaluate potential markers and risk factors, develop and evaluate an AMD classification scheme(s), and assess the progression of the disease and investigate factors that shape it. It is not practical to anticipate all of the potential uses of the data, or all the types of analyses that will be performed to address user-defined questions.


Recruitment information / eligibility

Status Completed
Enrollment 344
Est. completion date September 29, 2015
Est. primary completion date September 29, 2015
Accepts healthy volunteers No
Gender All
Age group 60 Years to 90 Years
Eligibility - INCLUSION CRITERIA:

To be eligible, the following inclusion criteria must be met, where applicable.

-Male or female participants must fall into any of the following categories:

- No drusen or any AMD-associated pigment abnormalities (no apparent aging changes)

- Small drusen (less than or equal to 63 micro millimeters in diameter) and the absence of AMD-associated pigment abnormalities in either eye (normal aging changes)

- Medium (>63 (Micro)m and less than or equal to 125 micro millimeters in diameter) drusen in either eye (Early AMD)

- Large (>125 (Micro)m in diameter) drusen with or without pigmentary abnormalities in either eye (Intermediate AMD)

- Neovascular AMD in only one eye or the presence of geographic atrophy in either eye but with vision >20/60 in the better-seeing eye (Late AMD)

- Presence of reticular Drusen in either eye

AMD classification will be based on clinical evaluation.

- 60 years of age or older

- Ability to provide written informed consent and comply with study assessments for the full duration of the study

- Retinal photographs of sufficient quality to allow assessment of the macular area for AMD lesions including drusen

EXCLUSION CRITERIA:

A participant is not eligible if any of the following exclusion criteria are present:

- Presence of lens or vitreous opacity in eye(s) with AMD to preclude adequate ophthalmic imaging

- Presence of ocular conditions that may now or in the future complicate the evaluation of AMD [e.g., vascular occlusion, diabetic retinopathy (>4 microaneurysms), etc.] in the eye(s) with AMD

- High myopia -6 Diopters or more severe

- Diagnosis of nystagmus

- Glaucoma with definite visual field defects. Participants with a history of the diagnosis of glaucoma, past or present use of medications to control intraocular pressure, or disc/nerve fiber layer defects suggestive of glaucoma can be eligible for the study if they have a documented normal Goldmann, Humphrey, or Octopus perimetry test within 6 months prior to qualification.

Study Design


Locations

Country Name City State
Germany University of Bonn Bonn
United States National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Eye Institute (NEI)

Countries where clinical trial is conducted

United States,  Germany, 

References & Publications (2)

Kini MM, Leibowitz HM, Colton T, Nickerson RJ, Ganley J, Dawber TR. Prevalence of senile cataract, diabetic retinopathy, senile macular degeneration, and open-angle glaucoma in the Framingham eye study. Am J Ophthalmol. 1978 Jan;85(1):28-34. — View Citation

Smiddy WE, Fine SL. Prognosis of patients with bilateral macular drusen. Ophthalmology. 1984 Mar;91(3):271-7. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Allow users to assess phenotypes of AMD 5 years
Primary Develop and evaluate potential markers and risk 5 years
Primary Develop and evaluate an AMD classification scheme(s) 5 years
Primary Assess the progression of the disease and investigate that shape it. 5 years
See also
  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