Diabetic RetinopathyNCT00001612
Long-Term Follow-Up of Patients Enrolled in the Early Treatment Diabetic Retinopathy Study (ETDRS)
An observational study of Diabetic Retinopathy, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
Patients enrolled in the original Early Treatment Diabetic Retinopathy Study at the Clinical Center at Johns Hopkins Wilmer Eye Institute will be invited for a follow-up visit at the National Eye Institute. Visual function will be assessed with manifest refraction and standardized visual acuity measurement. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diabetic Retinopathy
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- May 1997to Aug 2000
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Patient was originally enrolled in the Early Treatment Diabetic Retinopathy Study at the Johns Hopkins Wilmer Eye Institute.
Patient not previously enrolled are not eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Eye Institute (NEI)
Bethesda, Maryland, 20892
About this study
Patients enrolled in the original Early Treatment Diabetic Retinopathy Study at the Clinical Center at Johns Hopkins Wilmer Eye Institute will be invited for a follow-up visit at the National Eye Institute. Visual function will be assessed with manifest refraction and standardized visual acuity measurement. The progression of retinopathy will be evaluated by ocular exam and fundus photography. A brief medical history will be obtained. The goal of this study is to evaluate the long-term results of patients whose diabetic retinopathy was treated with different strategies of scatter and/or focal laser photocoagulation.
Read the detailed description
To evaluate the long-term clinical course and prognosis of diabetic retinopathy treated with different strategies of scatter and/or focal laser photocoagulation in patients enrolled in the Early Treatment Diabetic Retinopathy Study (ETDRS).
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetic Retinopathy, Long-Term Visual Outcome, Photocoagulation, J. H. Wilmer Eye Institute
- Medical subject headings
- Diabetic Retinopathy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startMay 1997
- Study completionAug 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 170 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001612
- Sponsor's protocol ID
- 970120
- Other IDs
- 97-EI-0120
- Status last verified
- May 1999
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Ferris FL 3rd. How effective are treatments for diabetic retinopathy? JAMA. 1993 Mar 10;269(10):1290-1. No abstract available.
PubMed 8437309
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Follow-Up of Patients Enrolled in the Early Treatment Diabetic Retinopathy Study (ETDRS)
- ClinicalTrials.gov ID
- NCT00001612
- Acronym / sponsor ID
- 970120
- Conditions
- Diabetic Retinopathy
- Keywords
- Diabetic Retinopathy, Long-Term Visual Outcome, Photocoagulation, J. H. Wilmer Eye Institute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 170 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- May 1997
- Study completion
- Aug 2000
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients enrolled in the original Early Treatment Diabetic Retinopathy Study at the Clinical Center at Johns Hopkins Wilmer Eye Institute will be invited for a follow-up visit at the National Eye Institute. Visual function will be assessed with manifest refraction and standardized visual acuity measurement. The progression of retinopathy will be evaluated by ocular exam and fundus photography. A brief medical history will be obtained. The goal of this study is to evaluate the long-term results of patients whose diabetic retinopathy was treated with different strategies of scatter and/or focal laser photocoagulation.
Detailed description
To evaluate the long-term clinical course and prognosis of diabetic retinopathy treated with different strategies of scatter and/or focal laser photocoagulation in patients enrolled in the Early Treatment Diabetic Retinopathy Study (ETDRS).
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 8437309Ferris FL 3rd. How effective are treatments for diabetic retinopathy? JAMA. 1993 Mar 10;269(10):1290-1. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. 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?
On the ClinicalTrials.gov record for NCT00001612, which also lists 1 linked publication.
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 4 Mar 2008.