Metabolic Mapping to Measure Retinal Metabolism

NCT00385333 | Completed Phase 2

• 2 other identifiers: 06025206-EI-0252
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test whether a new non-invasive technique can quickly and precisely measure retinal metabolism (the amount of energy retinal cells use). The retina is the part of the eye that sends information to the brain. Participants in current NEI studies who have age-related macular degeneration (AMD), diabetic retinopathy, or von Hippel-Landau disease may be eligible for this study. Healthy volunteers will participate as controls. Patients with AMD must be 60 years of age or older; those with VHL disease or diabetic retinopathy must be 18 or older. Participants undergo the tests and procedures required in the NEI study in which they previously enrolled. In addition, for the current study, they undergo metabolic mapping. For this procedure, the subject's eyes are dilated, and different amounts of low-level light are shone into the eye to see how different cells respond with changes in metabolism. Measurements are taken while the subject breathes room air and while he or she breathes medical grade oxygen for about 1 minute. The entire procedure takes about 15 minutes.

Conditions

Macular Degeneration; Diabetic Retinopathy; Hippel-Landau Disease; Mitochondria

Keywords

Mitochondrion; Retina; Mitochondria; Metabolism; In Vivo Imaging; Age-Related Macular Degeneration; AMD; Diabetic Retinopathy; DR; Hippel-Lindau Disease; VHL

Outcome Measures

Primary Outcomes (1)

• Fluorescence anisotropy

Secondary Outcomes (1)

• The difference in fluorescence anisotropy values within subjects under room air and 100% oxygen exposure (one minute exposure time).

Interventions

Feasibility Study - Imaging System PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ability and willingness to provide informed consent.
• Presence of a natural lens in the study eye(s).
• Media clarity, pupillary dilation, and cooperation sufficient to perform measurements.
• All participants will have the ability to read with at least 1 eye
• A diagnosis of AMD. We will use AREDS criteria and diagnostic scales for the definition of AMD.
• Men and women aged 60 years or older. Children are not included because AMD (by definition) is a disease afflicting adults.
• Eligible participants may have no evidence of AMD with little or no drusen in either eye, or may have any stage of AMD through end stage (geographic atrophic, retinal pigment epithelial detachment, or other signs of neovascular/exudative disease) in one eye.
• People with DR will be classified with the modified ETDRS scale; participants will have a range of severities of DR, with at least half classified in the severe non-proliferative DR category (SNPDR). Efforts will be made to recruit people with unilateral SNPDR.
• Participants will be men and women aged 18 years or older with diagnosis of diabetes mellitus (type 1 or type 2). Any one of the following will be considered sufficient evidence that diabetes is present:
• Current regular use of insulin for the treatment of diabetes.
• Current regular use of oral antihyperglycemia agents for the treatment of diabetes.
• Documented diabetes by ADA guidelines.
• Participants will be men and women aged 18 years or older with a genetic confirmation of VHL-disease.
• People with VHL disease exhibit a range of retinal lesions from none to severe.

You may not qualify if:

• Cataract surgery in the study eye.
• Glaucoma with evidence of optic nerve damage.
• Chronic requirement for any systemic or ocular medication for other eye diseases other than AMD, DR, or VHL-disease.
• Presence of implanted medical devices that may be affected by electromagnetic frequency (EMF) emissions. Although our equipment is CE or UL rated for EMF emissions it would be prudent to exclude people with implanted pacemakers, neural stimulators, and insulin pumps.
• Arrhythmia as indicated in medical records, as this may result in instability in measurements.
• History of seizures. The scanning mechanism of the system operates at 12 Hz, which may induce a seizure (n.b. a 12Hz scan rate is used in the Heidelberg HRTII and HRA).
• Presence of chronic obstructive pulmonary disease (COPD) or other lung disease that might make breathing 100% O2 unsafe.
• Ocular disease (other than AMD, DR, or VHL) that confounds assessment of the retina. These include but are not limited to central serous choroidopathy, optic atrophy, retinal vein occlusion, active uveitis, significant explained or unexplained visual field loss, or any other type of retinopathy or retinal degeneration.
• Vitreous hemorrhage.
• History of renal failure requiring dialysis or renal transplant.
• Existing condition that in the opinion of the investigator would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control).

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Congdon N, O'Colmain B, Klaver CC, Klein R, Munoz B, Friedman DS, Kempen J, Taylor HR, Mitchell P; Eye Diseases Prevalence Research Group. Causes and prevalence of visual impairment among adults in the United States. Arch Ophthalmol. 2004 Apr;122(4):477-85. doi: 10.1001/archopht.122.4.477.

  PMID: 15078664 BACKGROUND

• Beatty S, Koh H, Phil M, Henson D, Boulton M. The role of oxidative stress in the pathogenesis of age-related macular degeneration. Surv Ophthalmol. 2000 Sep-Oct;45(2):115-34. doi: 10.1016/s0039-6257(00)00140-5.

  PMID: 11033038 BACKGROUND

• Nyengaard JR, Ido Y, Kilo C, Williamson JR. Interactions between hyperglycemia and hypoxia: implications for diabetic retinopathy. Diabetes. 2004 Nov;53(11):2931-8. doi: 10.2337/diabetes.53.11.2931.

  PMID: 15504974 BACKGROUND

MeSH Terms

Conditions

Macular Degeneration; Diabetic Retinopathy; von Hippel-Lindau Disease

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Neurocutaneous Syndromes; Nervous System Diseases; Angiomatosis; Ciliopathies; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 6, 2006
• First Posted: October 9, 2006
• Study Start: September 29, 2006
• Primary Completion: June 1, 2008
• Study Completion: September 16, 2010
• Last Updated: July 2, 2017

Record last verified: 2010-09-16

Locations

US (1)