Diabetic RetinopathyNCT04018326
Loss to Follow-up in PDR Patients
An observational study of Diabetic Retinopathy, run by Assiut University.
Trial summary
This study determined the clinical impact and causes of loss to follow-up (LTFU) from the patients' perspective in individuals with proliferative diabetic retinopathy (PDR) who received panretinal photocoagulation (PRP) and/or intravitreal injections (IVIs) of anti-vascular endothelial growth factor (VEGF). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Diabetic Retinopathy
- How many people
- 467 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2013to 25 Dec 2018
- 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 40 to 70 years
- All sexes
- Adult, Older adult
Study population: patients who had developed PDR in one eye. Patients were allocated to receive PRP, IVIs of anti-VEGF, or a combination of both procedures.
Who may be able to join
- included treatment-naïve patients who had developed PDR in one eye with a best corrected visual acuity (BCVA) ranging from 20/22 to 20/69, as determined by the Snellen equivalent. Patients were allocated to receive PRP, IVIs of anti-VEGF, or a combination of both procedures.
Who cannot join
- patients receiving follow-up ophthalmic care for their PDR with or without interventions at any other medical care provider during the observation period, as declared by the patients at any follow up visit.
- patients LTFU who did not resume follow-up until the end of the observation period.
- patients needing PPV at first presentation or having additional retinal pathology. 4) patients receiving their treatment procedure during December 2017 or having vitreous hemorrhage that failed to clear up by June 2018 but still ineligible candidates for PPV.
About this study
Official title: Causes and Clinical Impact of Loss to Follow-up in Patients With Proliferative Diabetic Retinopathy
This study determined the clinical impact and causes of loss to follow-up (LTFU) from the patients' perspective in individuals with proliferative diabetic retinopathy (PDR) who received panretinal photocoagulation (PRP) and/or intravitreal injections (IVIs) of anti-vascular endothelial growth factor (VEGF).
This prospective cohort study included 467 patients with PDR who received PRP and/or IVIs of anti-VEGF between May 2013 and June 2018. LTFU was defined as missing any follow-up visit for any interval exceeding 6 months, provided that patients eventually resumed care. Main outcome measures include rates and causes of LTFU.
- Conditions
- Diabetic Retinopathy
- Keywords
- loss to follow-up, proliferative diabetic retinopathy, diabetic retinopathy, panretinal photocoagulation, intravitreal injections
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Compliant patients | The compliant patient was defined as a patient who did not miss any follow-up visit until the end of the study period. | |
| Loss to follow-up (LTFU) | LTFU was defined as missing any follow-up visit for any interval exceeding 6 months provided that patients eventually resumed care before the end of the study period (time zero was defined as the date of the missed follow-up visit). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final BCVA
logMAR BCVA at final follow up (Snellen equivalent)
Measured: "through study completion, an average of 1 year",
Final UCVA
Final logMAR UCVA (Snellen equivalent)
Measured: "through study completion, an average of 1 year",
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 May 2013
- Primary completion1 Jun 2018
- Study completion25 Dec 2018
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.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 467 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khaled Abdelazeem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018326
- Sponsor's protocol ID
- 17300291
- Status last verified
- Jul 2019
- First submitted
- 9 Jul 2019
- Last updated
- 12 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdelmotaal H, Ibrahim W, Sharaf M, Abdelazeem K. Causes and Clinical Impact of Loss to Follow-Up in Patients with Proliferative Diabetic Retinopathy. J Ophthalmol. 2020 Feb 8;2020:7691724. doi: 10.1155/2020/7691724. eCollection 2020.
PubMed 32089871
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Causes and Clinical Impact of Loss to Follow-up in Patients With Proliferative Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT04018326
- Acronym / sponsor ID
- 17300291
- Conditions
- Diabetic Retinopathy
- Keywords
- loss to follow-up, proliferative diabetic retinopathy, diabetic retinopathy, panretinal photocoagulation, intravitreal injections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 467 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2013 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 25 Dec 2018 (actual)
- First posted
- 12 Jul 2019 (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.
This study determined the clinical impact and causes of loss to follow-up (LTFU) from the patients' perspective in individuals with proliferative diabetic retinopathy (PDR) who received panretinal photocoagulation (PRP) and/or intravitreal injections (IVIs) of anti-vascular endothelial growth factor (VEGF).
This prospective cohort study included 467 patients with PDR who received PRP and/or IVIs of anti-VEGF between May 2013 and June 2018. LTFU was defined as missing any follow-up visit for any interval exceeding 6 months, provided that patients eventually resumed care. Main outcome measures include rates and causes of LTFU.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compliant patients | – | –The compliant patient was defined as a patient who did not miss any follow-up visit until the end of the study period. |
| Loss to follow-up (LTFU) | – | –LTFU was defined as missing any follow-up visit for any interval exceeding 6 months provided that patients eventually resumed care before the end of the study period (time zero was defined as the date of the missed follow-up visit). |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients who had developed PDR in one eye. Patients were allocated to receive PRP, IVIs of anti-VEGF, or a combination of both procedures.
Key inclusion criteria (1 listed)
- included treatment-naïve patients who had developed PDR in one eye with a best corrected visual acuity (BCVA) ranging from 20/22 to 20/69, as determined by the Snellen equivalent. Patients were allocated to receive PRP, IVIs of anti-VEGF, or a combination of both procedures.
Key exclusion criteria (3 listed)
- patients receiving follow-up ophthalmic care for their PDR with or without interventions at any other medical care provider during the observation period, as declared by the patients at any follow up visit.
- patients LTFU who did not resume follow-up until the end of the observation period.
- patients needing PPV at first presentation or having additional retinal pathology. 4) patients receiving their treatment procedure during December 2017 or having vitreous hemorrhage that failed to clear up by June 2018 but still ineligible candidates for PPV.
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
Final BCVA
Time frame: "through study completion, an average of 1 year",
logMAR BCVA at final follow up (Snellen equivalent)
Final UCVA
Time frame: "through study completion, an average of 1 year",
Final logMAR UCVA (Snellen equivalent)
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 12 Jul 2019.
- Derived from this study: PubMed 32089871Abdelmotaal H, Ibrahim W, Sharaf M, Abdelazeem K. Causes and Clinical Impact of Loss to Follow-Up in Patients with Proliferative Diabetic Retinopathy. J Ophthalmol. 2020 Feb 8;2020:7691724. doi: 10.1155/2020/7691724. eCollection 2020.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Retinopathy, run by Assiut University.
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 3 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 12 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Final BCVA (time frame: "through study completion, an average of 1 year",). The study lists 2 primary outcomes in all. 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 NCT04018326, 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 12 Jul 2019.