Subfoveal Choroidal ThicknessNCT06173245
Subfoveal Choroidal Thickness and Visual Acuity After Intravitreal Injection of Ranibizumab in Diabetic Retinopathy
A study testing Intravitreal injection of ranibizumab in people with Subfoveal Choroidal Thickness and Intravitreal, run by Egyptian Biomedical Research Network at 1 site in Egypt.
Trial summary
The aim of this study is to compare subfoveal choroidal thickness (SFCT) and the visual status before and after intravitreal injection of ranibizumab in diabetic macular edema (DME) with the use of 3D-OCT by enhanced depth spectral-domain imaging (EDI-OCT) with fixating other factors. Read more about this study
- Who is it for?
- Ages 50 to 70 years
- Conditions the study is for
- Subfoveal Choroidal Thickness, Intravitreal, Ranibizumab
- What is being tested?
- Intravitreal injection of ranibizumab
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to 1 Feb 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 50 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 50 to 70 years.
- Both sexes.
- Patients suffering from diabetic macular edema (DME).
Who cannot join
- High myopia more than 6 diopters.
- previous injections or retinal surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Change of Subfoveal Choroidal Thickness After Intravitreal Injection of Ranibizumab and Its Correlation With Visual Acuity in Diabetic Retinopathy
The aim of this study is to compare subfoveal choroidal thickness (SFCT) and the visual status before and after intravitreal injection of ranibizumab in diabetic macular edema (DME) with the use of 3D-OCT by enhanced depth spectral-domain imaging (EDI-OCT) with fixating other factors.
Read the detailed description
Diabetes is a metabolic disorder affecting the ocular vasculature. Although the principal posterior segment changes in diabetes usually occur in the retinal vasculature, additional changes are also observed in the choroid which provides an important blood supply to the outer retina. Diabetic choroidopathy involves choroidal abnormalities occurring in diabetic patients and may participate in mechanisms that lead to the decrease of visual acuity.
Several studies demonstrated the possibility of imaging of the choroid using spectral-domain OCT. Many studies investigated variation in the choroidal thickness (CT) occurring with changes in age and axial length, or in different ocular diseases, Diabetic macular edema (DME) is a major cause of visual loss in diabetic patients.
OCT (Optical coherence tomography) is a non-invasive imaging technique, that was used to obtain a high definition segments of retina. Lately, EDI (enhanced depth imaging) spectral-domain OCT has been explained. (EDI) program routinely captures a cross sectional picture with the choroid near the zero delay line to enhance sensitivity on the external edge of the choroid.
Functional imaging findings also presented a decrease in choroidal flow of the blood in eyes with diabetic retinopathy.
The current purpose of (EDI-OCT), which employing the enhanced depth of field from the inverted picture by locating the OCT device near to the eye, has helped the researchers to study the anatomic variations in the choroid in diabetic eyes.
- Conditions
- Subfoveal Choroidal Thickness, Intravitreal, Ranibizumab, Visual Acuity, Diabetic Retinopathy
- Being tested
- Intravitreal injection of ranibizumab
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal injection of ranibizumabProcedure or surgery
These patients were received three intravitreal injection of ranibizumab with one month interval. 3D-OCT by enhanced depth spectral-domain imaging (EDI-OCT) was done preoperative and a month after every injection.
All patients recieved topical anesthesia as 0.5 mg/0.05 ml , ranibizumab is injected 4 mm (3.5 mm in Pseudophakia) from the limbus intravitreally (in the lower temporal quadrant) by a needle (27gauge).
| Study group | Role | What they receive |
|---|---|---|
| Intravitreal injection of ranibizumab | Experimental | These patients were received three intravitreal injection of ranibizumab with one month interval. Receives: Procedure: Intravitreal injection of ranibizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of subfoveal choroidal thickness (SFCT)
All patients will be scheduled for subfoveal choroidal thickness (SFCT) evaluation on the first month, two month and three months by Optical coherence tomography (OCT).
Measured: 3 months
Secondary outcomes (1)
Change of visual acuity (VA)
Regular measurements of visual acuity (VA) over the evaluation visiting
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start1 Feb 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subfoveal Choroidal ThicknessStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Egyptian Biomedical Research Network
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Ekram Ragab Abdallah, Egyptian Biomedical Research Network
- Investigators
- Ekram R Abd-Allah, Master, Principal investigator, Ophthalmology Department, Faculty of Medicine-Al-Azhar University - Assiut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173245
- Sponsor's protocol ID
- MD/AZ.AST./OPH026/2/199/9/2021
- Status last verified
- Dec 2023
- First submitted
- 7 Dec 2023
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Change of Subfoveal Choroidal Thickness After Intravitreal Injection of Ranibizumab and Its Correlation With Visual Acuity in Diabetic Retinopathy
- ClinicalTrials.gov ID
- NCT06173245
- Acronym / sponsor ID
- MD/AZ.AST./OPH026/2/199/9/2021
- Conditions
- Subfoveal Choroidal Thickness, Intravitreal, Ranibizumab, Visual Acuity, Diabetic Retinopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Egyptian Biomedical Research NetworkResearch network
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 15 Dec 2023 (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.
The aim of this study is to compare subfoveal choroidal thickness (SFCT) and the visual status before and after intravitreal injection of ranibizumab in diabetic macular edema (DME) with the use of 3D-OCT by enhanced depth spectral-domain imaging (EDI-OCT) with fixating other factors.
Detailed description
Diabetes is a metabolic disorder affecting the ocular vasculature. Although the principal posterior segment changes in diabetes usually occur in the retinal vasculature, additional changes are also observed in the choroid which provides an important blood supply to the outer retina. Diabetic choroidopathy involves choroidal abnormalities occurring in diabetic patients and may participate in mechanisms that lead to the decrease of visual acuity.
Several studies demonstrated the possibility of imaging of the choroid using spectral-domain OCT. Many studies investigated variation in the choroidal thickness (CT) occurring with changes in age and axial length, or in different ocular diseases, Diabetic macular edema (DME) is a major cause of visual loss in diabetic patients.
OCT (Optical coherence tomography) is a non-invasive imaging technique, that was used to obtain a high definition segments of retina. Lately, EDI (enhanced depth imaging) spectral-domain OCT has been explained. (EDI) program routinely captures a cross sectional picture with the choroid near the zero delay line to enhance sensitivity on the external edge of the choroid.
Functional imaging findings also presented a decrease in choroidal flow of the blood in eyes with diabetic retinopathy.
The current purpose of (EDI-OCT), which employing the enhanced depth of field from the inverted picture by locating the OCT device near to the eye, has helped the researchers to study the anatomic variations in the choroid in diabetic eyes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intravitreal injection of ranibizumab | Experimental | Procedure: Intravitreal injection of ranibizumabThese patients were received three intravitreal injection of ranibizumab with one month interval. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age from 50 to 70 years.
- Both sexes.
- Patients suffering from diabetic macular edema (DME).
Key exclusion criteria (2 listed)
- High myopia more than 6 diopters.
- previous injections or retinal surgery.
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 |
|---|---|---|
| Intravitreal injection of ranibizumabThese patients were received three intravitreal injection of ranibizumab with one month interval. 3D-OCT by enhanced depth spectral-domain imaging (EDI-OCT) was done preoperative and a month after every injection. All patients recieved topical anesthesia as 0.5 mg/0.05 ml , ranibizumab is injected 4 mm (3.5 mm in Pseudophakia) from the limbus intravitreally (in the lower temporal quadrant) by a needle (27gauge). | Procedure or surgery | Intravitreal injection of ranibizumab |
Primary outcome
Change of subfoveal choroidal thickness (SFCT)
Time frame: 3 months
All patients will be scheduled for subfoveal choroidal thickness (SFCT) evaluation on the first month, two month and three months by Optical coherence tomography (OCT).
1 secondary outcome
Change of visual acuity (VA)
Time frame: 3 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 15 Dec 2023.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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.
Ekram R Abd-Allah, Master principal investigator
Ophthalmology Department, Faculty of Medicine-Al-Azhar University - Assiut
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravitreal injection of ranibizumab in people with Subfoveal Choroidal Thickness and Intravitreal, run by Egyptian Biomedical Research Network 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 3 inclusion and 2 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 15 Dec 2023. 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?
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?
Change of subfoveal choroidal thickness (SFCT) (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 15 Dec 2023.