Diabetic Macular EdemaNCT05494775
Effect of Corona Virus on Intravitreal Injections
A study testing Anti-vascular endothelial growth factors (Anti-VEGFs) in people with Diabetic Macular Edema and Age-Related Macular Degeneration, run by Benha University at 1 site in Egypt.
Trial summary
During pandemic of corona virus, patients compliance may be affected. We aim to study the factors lead to unregulated visits and its implications on the final visual outcome. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Diabetic Macular Edema, Age-Related Macular Degeneration, Choroidal Neovascularization
- What is being tested?
- Anti-vascular endothelial growth factors (Anti-VEGFs)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2019to 30 Jul 2023
- Phase
- Interventional
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with the following conditions (diabetic macular edema, wet age related macular degeneration, myopic choroidal new vascularization and retinal vein occlusion complicated with macular edema).
Who cannot join
- patients that are known to have hypersensitivity to Anti-VEGFs.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ahmed Abdelshafy Tabl
Banhā, Benha, 13511
Ahmed A Tabl, 01222328766, ahmad4lg@gmail.com
About this study
Official title: Effects of Corona Virus Pandemic on Intravitreal Injections
During pandemic of corona virus, patients compliance may be affected. We aim to study the factors lead to unregulated visits and its implications on the final visual outcome.
Read the detailed description
The corona virus pandemic may affects patients regular visits to ophthalmic clinic, we aim to study the sequel of the pandemic on intravitreal injections results in diabetic macular edema, wet age related macular degenerations, myopic choroidal new vascularization, and proliferative diabetic retinopathy.
- Conditions
- Diabetic Macular Edema, Age-Related Macular Degeneration, Choroidal Neovascularization, Myopic Choroidal Neovascularisation, Diabetic Retinopathy
- Being tested
- Anti-vascular endothelial growth factors (Anti-VEGFs)
- Medical subject headings
- Macular Degeneration, Choroidal Neovascularization, Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-vascular endothelial growth factors (Anti-VEGFs)Drug
Intravitreal injection of anti-vascular endothelial growth factors (Anti-VEGFs).
| Study group | Role | What they receive |
|---|---|---|
| Diabetic macular edema | Active comparator | Cases with diabetic macular edema that are prepared for intravitreal injection of anti-vascular endothelial growth factors. Receives: Drug: Anti-vascular endothelial growth factors (Anti-VEGFs) |
| Wet age related macular edema | Active comparator | Cases with wet age related macular degenerations that are prepared for intravitreal injection of anti-vascular endothelial growth factors. Receives: Drug: Anti-vascular endothelial growth factors (Anti-VEGFs) |
| Retinal vein occlusion | Active comparator | Cases with macular edema secondary to retinal vein occlusion that are prepared for intravitreal injection of anti-vascular endothelial growth factors. Receives: Drug: Anti-vascular endothelial growth factors (Anti-VEGFs) |
| Myopic choroidal new vascularization | Active comparator | Cases with myopic choroidal new vascularization that are prepared for intravitreal injection of anti-vascular endothelial growth factors. Receives: Drug: Anti-vascular endothelial growth factors (Anti-VEGFs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Assessing the changes in best corrected visual acuity in logMAR unit measured by snellen chart.
Measured: Baseline and monthly after injection till one year of follow-up
Secondary outcomes (1)
Central subfield thickness
Assessing the changes in central macular thickness in microns measured by optical coherence tomography
Measured: Baseline and monthly after injection till one year of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2022
- Study start1 Feb 2019
- Primary completion11 Jun 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies of the same condition, open and under way.
- More trials run by Benha 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelshafy, Benha University
- Investigators
- Ahmed A Tabl, Principal investigator, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494775
- Sponsor's protocol ID
- Rc-11-2022
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2022
- Last updated
- 10 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Corona Virus Pandemic on Intravitreal Injections
- ClinicalTrials.gov ID
- NCT05494775
- Acronym / sponsor ID
- Rc-11-2022
- Conditions
- Diabetic Macular Edema, Age-Related Macular Degeneration, Choroidal Neovascularization, Myopic Choroidal Neovascularisation, Diabetic Retinopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 11 Jun 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 10 Aug 2022 (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.
During pandemic of corona virus, patients compliance may be affected. We aim to study the factors lead to unregulated visits and its implications on the final visual outcome.
Detailed description
The corona virus pandemic may affects patients regular visits to ophthalmic clinic, we aim to study the sequel of the pandemic on intravitreal injections results in diabetic macular edema, wet age related macular degenerations, myopic choroidal new vascularization, and proliferative diabetic retinopathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Diabetic macular edema | Active comparator | Drug: Anti-vascular endothelial growth factors (Anti-VEGFs)Cases with diabetic macular edema that are prepared for intravitreal injection of anti-vascular endothelial growth factors. |
| Wet age related macular edema | Active comparator | Drug: Anti-vascular endothelial growth factors (Anti-VEGFs)Cases with wet age related macular degenerations that are prepared for intravitreal injection of anti-vascular endothelial growth factors. |
| Retinal vein occlusion | Active comparator | Drug: Anti-vascular endothelial growth factors (Anti-VEGFs)Cases with macular edema secondary to retinal vein occlusion that are prepared for intravitreal injection of anti-vascular endothelial growth factors. |
| Myopic choroidal new vascularization | Active comparator | Drug: Anti-vascular endothelial growth factors (Anti-VEGFs)Cases with myopic choroidal new vascularization that are prepared for intravitreal injection of anti-vascular endothelial growth factors. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with the following conditions (diabetic macular edema, wet age related macular degeneration, myopic choroidal new vascularization and retinal vein occlusion complicated with macular edema).
Key exclusion criteria (1 listed)
- patients that are known to have hypersensitivity to Anti-VEGFs.
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 |
|---|---|---|
| Anti-vascular endothelial growth factors (Anti-VEGFs)Intravitreal injection of anti-vascular endothelial growth factors (Anti-VEGFs). | Drug | Diabetic macular edema, Myopic choroidal new vascularization, Retinal vein occlusion, Wet age related macular edema |
Primary outcome
Visual acuity
Time frame: Baseline and monthly after injection till one year of follow-up
Assessing the changes in best corrected visual acuity in logMAR unit measured by snellen chart.
1 secondary outcome
Central subfield thickness
Time frame: Baseline and monthly after injection till one year of follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2022.
- 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.
Ahmed A Tabl principal investigator
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-vascular endothelial growth factors (Anti-VEGFs) in people with Diabetic Macular Edema and Age-Related Macular Degeneration, run by Benha University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 10 Aug 2022. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Tabl, MD (01222328766, ahmad4lg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: Baseline and monthly after injection till one year of follow-up). 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 10 Aug 2022.