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AzTrials

Macular DegenerationPhase 2NCT00385333

Metabolic Mapping to Measure Retinal Metabolism

A Phase 2 study testing Feasibility Study - Imaging System in people with Macular Degeneration and Diabetic Retinopathy, run by National Eye Institute (NEI) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Feasibility Study - Imaging System
Type of treatment
Surgery or procedure
How many people
28 participants
Where
1 siteUnited States
Study dates
29 Sep 2006to 16 Sep 2010
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • GENERAL INCLUSION CRITERIA:
  • 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
  • AMD-SPECIFIC INCLUSION CRITERIA:
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  • Participants will range from those with no AMD and little or no drusen in either eye through end stage AMD (geographic atrophic, retinal pigment epithelial detachment, or other signs of neovascular/exudative disease) in one eye. Participants will be classified with the AREDS System for Classifying Age-Related Macular Degeneration and will exhibit a range of severities of AMD with at least half exhibiting unilateral advanced AMD (geographic atrophy or neovascular AMD) and half at high risk of progression. Inclusion criteria are as follows:
  • 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.
  • DR-SPECIFIC INCLUSION CRITERIA:
  • 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.
  • VHL-SPECIFIC INCLUSION CRITERIA:
  • 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.

Who cannot join

  • GENERAL EXCLUSION CRITERIA:
  • 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.
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  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: A Novel Non-Invasive In Vivo Imaging System to Measure Retinal Metabolism

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.

Read the detailed description

Background. Alterations in retinal metabolism are associated with blinding conditions and vision loss. We propose to apply a non-invasive in vivo retinal imaging system to investigate key physiologic processes affecting retinal metabolism. The imaging system is designed to quantify and characterize the topology of retinal metabolism in 3-dimensional space across 40--130 picosecond time periods and allows dynamic measurement of physiologically relevant events.

Objectives. The primary objectives of our study are to: (1) evaluate the utility of this system in a clinical setting; and (2) examine variation in retinal metabolism within retinal cell subtypes under environmental conditions optimized to support this metabolism. The working hypothesis of our first objective is that the imaging system will be easily and efficiently implemented in a clinical setting and will yield stable and repeatable results. The working hypothesis for our second objective is that people with or at high risk for progression to sight threatening retinal disease will exhibit different metabolic profiles than an age- and sex-matched disease-free comparison group. Their peers with less severe disease may exhibit differences with severe diseased and non-diseased groups. The long-term goal of the project is to address the following research questions: Are metabolic profiles generated by the imaging system effective for determining presence and severity of retinal diseases?; and if so, are these metabolic profiles useful in identifying people at risk for progression to sight threatening forms of retinal diseases?

Study Population. We will first apply the systems in 3 groups of 10 people exhibiting a range of severity in retinal diseases that influence retinal metabolism; these diseases are: age-related macular degeneration (AMD); diabetic retinopathy (DR); and von-Hippel-Lindau (VHL) disease.

Design. Cross-sectional sampling design. If the system yields accurate, stable, and repeatable results it will be applied in longitudinal studies to evaluate prognostic utility for estimating the risk of progression to sight-threatening AMD, DR, or VHL disease.

Outcome Measures. The magnitude and 3-D topographic profile of fluorescence anisotropy values across physiologically meaningful time periods for a 20 degree field centered on the macula. Fluorescence anisotropy of our system provides a measure of retinal metabolism.

Being tested
Feasibility Study - Imaging System
Keywords
Mitochondrion, Retina, Mitochondria, Metabolism, In Vivo Imaging, Age-Related Macular Degeneration, AMD, Diabetic Retinopathy, DR, Hippel-Lindau Disease, VHL
Medical subject headings
Macular Degeneration, Diabetic Retinopathy, von Hippel-Lindau Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Feasibility Study - Imaging SystemProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fluorescence anisotropy

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2006 (estimated)
  2. Study start29 Sep 2006
  3. Primary completion1 Jun 2008
  4. Study completion16 Sep 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00385333
Sponsor's protocol ID
060252
Other IDs
06-EI-0252
Status last verified
16 Sep 2010
First submitted
6 Oct 2006
Last updated
2 Jul 2017
Results posted
No

Publications

  • 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.

    PubMed 15078664

  • 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.

    PubMed 11033038

  • 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.

    PubMed 15504974

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Feasibility Study - Imaging System in people with Macular Degeneration and Diabetic Retinopathy, run by National Eye Institute (NEI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fluorescence anisotropy. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00385333, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.

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