Retinopathy, DiabeticNCT03345667
Assessment of Color Vision in Diabetic Patients
An observational study of Retinopathy, Diabetic, run by Instituto de Olhos de Goiania at 1 site in Brazil.
Trial summary
Assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema Read more about this study
- Who is it for?
- Ages 1 year to 100 years
- Conditions the study is for
- Retinopathy, Diabetic
- What is being tested?
- lucentis
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Aug 2017to 30 Oct 2017
- 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 1 year to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema. Using the Ishirara's test to evaluate the possible visual loss.
Who may be able to join
- Having diabetic retinopathy with macular edema
Who cannot join
- Not having diabetic retinopathy with macular edema
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Color Vision in Diabetic Patients Before and After the Use of Anti-vegf in the Treatment of Diabetic Macular Edema
Assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema
- Conditions
- Retinopathy, Diabetic
- Being tested
- lucentis
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lucentisDrug
Use of lucentis and other anti-vegf in patients with diabetic retinopathy
| Study group | Role | What they receive |
|---|---|---|
| Anti-Vegf | Use intravitreous anti-vegf Receives: Drug: lucentis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema
Using the Ishihara's test to analise the possible loss of vision
Measured: 3 months
Secondary outcomes (1)
Frame between the injections
Ant-Vegf
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Aug 2017
- Primary completion1 Oct 2017
- Study completion30 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinopathy, DiabeticStudies 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
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Olhos de Goiania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03345667
- Sponsor's protocol ID
- TRABALHO PEDRO ARVO 2018
- Status last verified
- Nov 2017
- First submitted
- 7 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Color Vision in Diabetic Patients Before and After the Use of Anti-vegf in the Treatment of Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT03345667
- Acronym / sponsor ID
- TRABALHO PEDRO ARVO 2018
- Conditions
- Retinopathy, Diabetic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Instituto de Olhos de GoianiaUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 30 Oct 2017 (actual)
- First posted
- 17 Nov 2017 (actual)
- 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.
Assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anti-Vegf | – | Drug: lucentisUse intravitreous anti-vegf |
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema. Using the Ishirara's test to evaluate the possible visual loss.
Key inclusion criteria (1 listed)
- Having diabetic retinopathy with macular edema
Key exclusion criteria (1 listed)
- Not having diabetic retinopathy with macular edema
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lucentisUse of lucentis and other anti-vegf in patients with diabetic retinopathy | Drug | Anti-Vegf |
Primary outcome
Assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema
Time frame: 3 months
Using the Ishihara's test to analise the possible loss of vision
1 secondary outcome
Frame between the injections
Time frame: 1 months
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 17 Nov 2017.
- Individual participant dataSharing planned: No
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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 Retinopathy, Diabetic, run by Instituto de Olhos de Goiania at 1 site in Brazil.
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 1 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 17 Nov 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 Brazil. 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.
What does the primary outcome measure?
Assessment of color vision in diabetic patients before and after the use of anti-vegf in the treatment of diabetic macular edema (time frame: 3 months). It is what the study was designed to measure, not a finding.
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 17 Nov 2017.