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Retinal DiseaseNCT00005784

Evaluation and Treatment of Patients With Retinal Disease

An observational study of Retinal Disease, 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 offers evaluation and treatment for patients with certain diseases of the retina (the layer of light-sensitive tissue that lines the inside of the eyeball). The protocol is not designed to test new treatments; rather, patients will receive the current standard of care for his or her specific condition. Read more about this study

Who is it for?
Ages 10 years and older
Conditions the study is for
Retinal Disease
How many people
1,000 participants
Where
1 siteUnited States
Study dates
31 May 2000to 8 Aug 2008
Phase
Observational
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 10 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Each study participant must have the ability to understand and sign an informed consent form.
  • Patients with diabetic retinopathy and age-related macular degeneration.
  • Patients with vascular occlusive disease, central serous retinopathy, or rare/unknown retinal disease.

Who cannot join

  • Patients will be excluded from this study if they are unable or unwilling to give informed consent or they are unwilling to be followed and treated at the NEI Clinical Center for at least the next 3 years.

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: Evaluation and Treatment Protocol for Patients With Retinal Disease

This study offers evaluation and treatment for patients with certain diseases of the retina (the layer of light-sensitive tissue that lines the inside of the eyeball). The protocol is not designed to test new treatments; rather, patients will receive the current standard of care for his or her specific condition. The purpose of the study is twofold: 1) to allow National Eye Institute physicians to increase their knowledge of retinal eye diseases and identify possible new avenues of research in this area; and 2) to establish a pool of patients who may be eligible for new studies as they are developed. (Participants in this protocol will not be required to join a new study; the decision will be voluntary.)

Patients with diabetic retinopathy, age-related macular degeneration, vascular occlusive disease, central serous retinopathy or another retinal disease may be eligible for this study. Candidates will be screened with a medical history, brief physical examination, thorough eye examination and blood test. The eye examination includes measurements of eye pressure and visual acuity (ability to see the vision chart), examination of the pupils and eye movements, and dilation of the pupils to examine the lens and retina. Patients will also undergo fundus photography and fluorescein angiography, as follows:

Read more
  • Fundus photography - Special photographs of the inside of the eye to help evaluate the status of the retina and evaluate changes that may occur in the future. From 2 to 20 pictures may be taken, depending on the eye condition. The camera flashes a bright light into the eye for each picture.
  • Fluorescein angiography - Procedure to evaluate the eye's blood vessels. A yellow dye injected into an arm vein travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality.

Participants will be followed at least 3 years. Follow-up visits are scheduled according to the standard of care for the individual patient's eye problem. It is estimated that most patients will have from one to four follow-up visits each year. Vision will be checked at each visit, and some of the screening tests described above may be repeated to follow the progress of disease and evaluate the response to treatment.

Read the detailed description

This 'Evaluation and Treatment Protocol' will allow the retinal specialists at the NEI to identify, follow and provide "standard of care" treatment to patients with various retinal diseases. A primary purpose of the protocol is to accumulate a cohort of patients with retinal diseases for possible participation in new clinical trials and epidemiological protocols. Also, by providing long-term follow-up and treatment for a variety of retinal diseases, the retinal specialists at NEI will be better able to identify research hypotheses about these diseases in addition to maintaining their clinical skills. The availability of cohorts of patients with a spectrum of retinal diseases will be valuable for the training of retinal fellows, an important mission of the NEI. The ability to provide long-term follow-up and care will also facilitate referral efforts for new NEI protocols.

The retinal specialists at the National Eye Institute will be free to choose those retinal diseases that interest them. However, the total number of patients that can be enrolled in the protocol will be restricted. This protocol is not designed to test any new treatments. Any evaluations or treatment under this protocol will be based on the current standard of care for each retinal disease.

Participants in this patient evaluation and treatment protocol will be evaluated for potential eligibility in any new NEI clinical trials or epidemiologic protocols as they are developed. If eligible, patients may be asked to participate in the new protocol. However, they will not be required to enter any protocol and their decision to participate will be entirely voluntary. No more than 150 patients will be accepted in this "Evaluation and Treatment Protocol."

Conditions
Retinal Disease
Keywords
Macular Degeneration, Diabetic Retinopathy, Vascular Occlusive Disease, Central Serous Retinopathy, Rare/Unknown Retinal Disease, Retinal Disease, Age-Related Macular Degeneration
Medical subject headings
Retinal Diseases, Macular Degeneration, Diabetic Retinopathy, Central Serous Chorioretinopathy

Timeline

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

  1. First posted5 Jun 2000 (estimated)
  2. Study start31 May 2000
  3. Study completion8 Aug 2008

Resources

More details

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

Study design
Study type
Observational
Enrolment
1,000 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00005784
Sponsor's protocol ID
000139
Other IDs
00-EI-0139
Status last verified
8 Aug 2008
First submitted
3 Jun 2000
Last updated
2 Jul 2017
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Retinal Disease, 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 3 inclusion and 1 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.

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.

Where can I read the original study information?
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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