SafetySCINCT04069780
Suprachoroidal Injection of Triamcinolone Acetonide for Management of Diabetic Macular Edema
A study testing Intravitreal injection (4mg/0.1ml), Superachoroidal injection (4 mg/0.1ml) and Suprachoroidal injection (2mg/0.1ml) in people with Safety and Efficacy, run by Azza Mohamed Ahmed Said at 1 site in Egypt.
Trial summary
Intravitreal triamcinolone acetonide is a well-known method of treatment of diabetic macular edema, however, it has many side effects, most commonly causing cataract and glaucoma. Suprachoroidal route is an emerging route of delivery of intraocular drugs. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- What is being tested?
- Intravitreal injection (4mg/0.1ml), Superachoroidal injection (4 mg/0.1ml) and Suprachoroidal injection (2mg/0.1ml)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Mar 2019to 7 Aug 2021
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type-II Diabetes Mellitus patients.
- Centrally involving DME with central thickness<300µm with no vitreomacular traction.
- Recently diagnosed DME or received treatment for DME in more than six months.
Who cannot join
- Pre-existingretinal disease other than diabetic retinopathy.
- Diabetic macular ischemia.
- IOP ≥ 21 mmHg and/or asymmetrical cup disc ratio or glaucoma patients.
- Prior cataract extraction of less than six months.
- Opaque media, uncooperative patients or patients with poor fixation.
- Any uncontrolled systemic disease.
- Systemic or local medicationsthat might affect the macular thickness
Trial locations and contacts
1 site in 1 country.
Yousra GZ Selim, Msc contact
About this study
Official title: Comparative Study Between Intravitreal and Suprachoroidal Injection of Triamcinolone Acetonide for Management of Diabetic Macular Edema
Intravitreal triamcinolone acetonide is a well-known method of treatment of diabetic macular edema, however, it has many side effects, most commonly causing cataract and glaucoma. Suprachoroidal route is an emerging route of delivery of intraocular drugs.
This is to our knowledge the first prospective study to compare the effect of triamcinolone acetonide delivered via the intravitreal versus the suprachoroidal route in the treatment of diabetic macular edema as regards safety and efficacy.
Read the detailed description
The purposes of this study were:
- To compare between intravitreal and suprachoroidalTA injection for treatment of DME in terms of improvement in both best corrected visual acuity (BCVA) and central macular thickness (CMT), and development of complications.
- To identify which dose of TA will be efficient using the suprachoroidal route.
- Type of Study: A prospective interventional randomized comparative study.
- Study setting:Ophthalmology Department, Ain Shams University.
- Study period:2 years.
- Study population: Patients having DME.
- Sample size: The study will be conducted on 45 eyes. This was done using PASS program, setting alpha error at 5% and power at 80%. Results from previous study (Koc et al., 2017) showed that the mean improvement in BCVA after 6 months of intravitreal injection of TA was 4.6 ± 8.8. While it is assumed to be 12.6 and 14.6 for the low dose and high dose suprachoroidal route.
- Ethical considerations: Explanation of the procedure will be done for all patients and an informed written consent will be taken. Ethics committee approval will be obtained from the Institutional Review Board of the Faculty of Medicine, Ain Shams University.
All patients will undergo the following at initial presentation:
- Careful history taking.
- Full ophthalmological assessment including:
Baseline BCVA. Anterior segment examination using slit lamp biomicroscopy. IOP measurement using Goldmann applanation tonometer. Posterior segment examination using binocular indirect ophthalmoscopy and indirect slit lamp biomicroscopy (+90D Volk lens) for detailed evaluation of the macula and optic nerve head.
Fundus photography using VX-20 Kowa fundus camera, Japan. Ultrasound biomicroscopy (UBM) for measurement of scleral thickness in groups (II) and (III)using VuMax, Sonomed Escalon, theUnited States of America.
Spectral domain optical coherence tomography (SD-OCT) imaging using Retinascan RS 3000 advance, Nidek co.ltd, Gamgori, Japan.
Examination protocol: Macular map and 12 radial line scans to determine central macular thickness (1mm) and macular thickness in the inner 3 and 6 mm rings divided each into four quadrants.
Duration of follow up: 6 months.
Follow up schedule:
Follow up visits will be done at 1 day, 1 week, 1 month,3 months and 6 months.During the follow up, the following will be done:
- BCVA measurement.
- Full ophthalmological examination.
- Fundus photography after six months of injection.
- CMT measurement using SD-OCT at 1,3 and 6 months post-injection. In case of resistance to treatment (worsening of BCVA or CMT, or persistence of macular edema with central thickness less than 300µm), reinjection will be considered using the same drug and/or anti-VEGF agents.
- Being tested
- Intravitreal injection (4mg/0.1ml), Superachoroidal injection (4 mg/0.1ml), Suprachoroidal injection (2mg/0.1ml)
- Keywords
- Suprachoroidal injection, Diabetic macular edema, Tiamicinolone acetonide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravitreal injection (4mg/0.1ml)Procedure or surgery
Injection will be performed in the operating room under complete sterile conditions Under topical anaesthesia. Intravitreal injection (4mg/0.1ml) of triamicinolone acetonide will be done using a 30-31 gauge needle at a distance of 3.5 mm from the limbus in aphakic or pseudophakic patients, and 4 mm in phakic patients. The needle will be then removed with application of cotton tipped applicator over the entry site.
-IOP monitoring will be done at 15, 30 and 60 minutes following injection in all groups.
Superachoroidal injection (4 mg/0.1ml)Procedure or surgery
Injection will be performed in the operating room under complete sterile conditions Under topical anaesthesia. Suprachoroidal injection (4mg/0.1ml) of triamcinolone acetonide will be done using a custom-made 30-31 gauge needle with a sleeve to prevent further penetration of the needle into the vitreous cavity. Injection will be done at approximately 4 mm from the limbus.
- IOP monitoring will be done at 15, 30 and 60 minutes following injection in all groups.
- UBM assessment will be done 24 hours following injection to confirm targeting of the suprachoroidal space.
Suprachoroidal injection (2mg/0.1ml)Procedure or surgery
njection will be performed in the operating room under complete sterile conditions Under topical anaesthesia. Suprachoroidal injection (2mg/0.1ml) of triamcinolone acetonide will be done using a custom-made 30-31 gauge needle with a sleeve to prevent further penetration of the needle into the vitreous cavity. Injection will be done at approximately 4 mm from the limbus.
- IOP monitoring will be done at 15, 30 and 60 minutes following injection in all groups.
- UBM assessment will be done 24 hours following injection to confirm targeting of the suprachoroidal space.
| Study group | Role | What they receive |
|---|---|---|
| Study group I : Intravitreal injection | Active comparator | A single intravitreal injection of 0.1 ml triamcinolone acetonide in a concentration of 4 mg / 0.1 ml. Receives: Procedure: Intravitreal injection (4mg/0.1ml) |
| Study group II: Suprachoroidal injection of full dose | Active comparator | A single suprachoroidal injection of 0.1 ml triamcinolone acetonide in a concentration of 4 mg / 0.1 ml. Receives: Procedure: Superachoroidal injection (4 mg/0.1ml) |
| Study group III : Suprachoroidal injection of half dose | Active comparator | They will receive a single suprachoroidal injection of 0.1 ml triamcinolone acetonide in a concentration of 2 mg / 0.1 ml. Receives: Procedure: Suprachoroidal injection (2mg/0.1ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity (BCVA)
Change in BCVA (Log.MAR) equal or more than 1 line
Measured: Six months after injection
Secondary outcomes (2)
Central macular thickness (CMT)
Change in CMT (um) equal or more than 50 um
Measured: Six months after injection
Complications
e.g. change in intraocular pressure
Measured: During the six months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start13 Mar 2019
- Primary completion7 Aug 2020 (estimated)
- Study completion7 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SafetyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azza Mohamed Ahmed Said
- Sponsor type
- University, hospital or other
- Collaborators
- Ain Shams University
- Responsible party
- Sponsor-investigator, Azza Mohamed Ahmed Said, Ain Shams University
- Investigators
- Abdelrahman G Salman, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069780
- Sponsor's protocol ID
- AinShamsU1
- Acronym
- SCI
- Status last verified
- Aug 2019
- First submitted
- 23 Aug 2019
- Last updated
- 3 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Intravitreal and Suprachoroidal Injection of Triamcinolone Acetonide for Management of Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT04069780
- Acronym / sponsor ID
- SCI / AinShamsU1
- Keywords
- Suprachoroidal injection, Diabetic macular edema, Tiamicinolone acetonide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Azza Mohamed Ahmed SaidUniversity, hospital or other
- Collaborators
- Ain Shams University
- Study start
- 13 Mar 2019 (actual)
- Primary completion
- 7 Aug 2020 (estimated)
- Study completion
- 7 Aug 2021 (estimated)
- First posted
- 28 Aug 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.
Intravitreal triamcinolone acetonide is a well-known method of treatment of diabetic macular edema, however, it has many side effects, most commonly causing cataract and glaucoma. Suprachoroidal route is an emerging route of delivery of intraocular drugs.
This is to our knowledge the first prospective study to compare the effect of triamcinolone acetonide delivered via the intravitreal versus the suprachoroidal route in the treatment of diabetic macular edema as regards safety and efficacy.
Detailed description
The purposes of this study were:
- To compare between intravitreal and suprachoroidalTA injection for treatment of DME in terms of improvement in both best corrected visual acuity (BCVA) and central macular thickness (CMT), and development of complications.
- To identify which dose of TA will be efficient using the suprachoroidal route.
- Type of Study: A prospective interventional randomized comparative study.
- Study setting:Ophthalmology Department, Ain Shams University.
- Study period:2 years.
- Study population: Patients having DME.
- Sample size: The study will be conducted on 45 eyes. This was done using PASS program, setting alpha error at 5% and power at 80%. Results from previous study (Koc et al., 2017) showed that the mean improvement in BCVA after 6 months of intravitreal injection of TA was 4.6 ± 8.8. While it is assumed to be 12.6 and 14.6 for the low dose and high dose suprachoroidal route.
- Ethical considerations: Explanation of the procedure will be done for all patients and an informed written consent will be taken. Ethics committee approval will be obtained from the Institutional Review Board of the Faculty of Medicine, Ain Shams University.
All patients will undergo the following at initial presentation:
- Careful history taking.
- Full ophthalmological assessment including:
Baseline BCVA. Anterior segment examination using slit lamp biomicroscopy. IOP measurement using Goldmann applanation tonometer. Posterior segment examination using binocular indirect ophthalmoscopy and indirect slit lamp biomicroscopy (+90D Volk lens) for detailed evaluation of the macula and optic nerve head.
Fundus photography using VX-20 Kowa fundus camera, Japan. Ultrasound biomicroscopy (UBM) for measurement of scleral thickness in groups (II) and (III)using VuMax, Sonomed Escalon, theUnited States of America.
Spectral domain optical coherence tomography (SD-OCT) imaging using Retinascan RS 3000 advance, Nidek co.ltd, Gamgori, Japan.
Examination protocol: Macular map and 12 radial line scans to determine central macular thickness (1mm) and macular thickness in the inner 3 and 6 mm rings divided each into four quadrants.
Duration of follow up: 6 months.
Follow up schedule:
Follow up visits will be done at 1 day, 1 week, 1 month,3 months and 6 months.During the follow up, the following will be done:
- BCVA measurement.
- Full ophthalmological examination.
- Fundus photography after six months of injection.
- CMT measurement using SD-OCT at 1,3 and 6 months post-injection. In case of resistance to treatment (worsening of BCVA or CMT, or persistence of macular edema with central thickness less than 300µm), reinjection will be considered using the same drug and/or anti-VEGF agents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study group I : Intravitreal injection | Active comparator | Procedure: Intravitreal injection (4mg/0.1ml)A single intravitreal injection of 0.1 ml triamcinolone acetonide in a concentration of 4 mg / 0.1 ml. |
| Study group II: Suprachoroidal injection of full dose | Active comparator | Procedure: Superachoroidal injection (4 mg/0.1ml)A single suprachoroidal injection of 0.1 ml triamcinolone acetonide in a concentration of 4 mg / 0.1 ml. |
| Study group III : Suprachoroidal injection of half dose | Active comparator | Procedure: Suprachoroidal injection (2mg/0.1ml)They will receive a single suprachoroidal injection of 0.1 ml triamcinolone acetonide in a concentration of 2 mg / 0.1 ml. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type-II Diabetes Mellitus patients.
- Centrally involving DME with central thickness<300µm with no vitreomacular traction.
- Recently diagnosed DME or received treatment for DME in more than six months.
Key exclusion criteria (7 listed)
- Pre-existingretinal disease other than diabetic retinopathy.
- Diabetic macular ischemia.
- IOP ≥ 21 mmHg and/or asymmetrical cup disc ratio or glaucoma patients.
- Prior cataract extraction of less than six months.
- Opaque media, uncooperative patients or patients with poor fixation.
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 (4mg/0.1ml)Injection will be performed in the operating room under complete sterile conditions Under topical anaesthesia. Intravitreal injection (4mg/0.1ml) of triamicinolone acetonide will be done using a 30-31 gauge needle at a distance of 3.5 mm from the limbus in aphakic or pseudophakic patients, and 4 mm in phakic patients. The needle will be then removed with application of cotton tipped applicator over the entry site. -IOP monitoring will be done at 15, 30 and 60 minutes following injection in all groups. | Procedure or surgery | Study group I : Intravitreal injection |
| Superachoroidal injection (4 mg/0.1ml)Injection will be performed in the operating room under complete sterile conditions Under topical anaesthesia. Suprachoroidal injection (4mg/0.1ml) of triamcinolone acetonide will be done using a custom-made 30-31 gauge needle with a sleeve to prevent further penetration of the needle into the vitreous cavity. Injection will be done at approximately 4 mm from the limbus. * IOP monitoring will be done at 15, 30 and 60 minutes following injection in all groups. * UBM assessment will be done 24 hours following injection to confirm targeting of the suprachoroidal space. | Procedure or surgery | Study group II: Suprachoroidal injection of full dose |
| Suprachoroidal injection (2mg/0.1ml)njection will be performed in the operating room under complete sterile conditions Under topical anaesthesia. Suprachoroidal injection (2mg/0.1ml) of triamcinolone acetonide will be done using a custom-made 30-31 gauge needle with a sleeve to prevent further penetration of the needle into the vitreous cavity. Injection will be done at approximately 4 mm from the limbus. * IOP monitoring will be done at 15, 30 and 60 minutes following injection in all groups. * UBM assessment will be done 24 hours following injection to confirm targeting of the suprachoroidal space. | Procedure or surgery | Study group III : Suprachoroidal injection of half dose |
Primary outcome
Best Corrected Visual Acuity (BCVA)
Time frame: Six months after injection
Change in BCVA (Log.MAR) equal or more than 1 line
2 secondary outcomes
Central macular thickness (CMT)
Time frame: Six months after injection
Complications
Time frame: During the six months after injection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2019.
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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.
Yousra GZ Selim, Msc contact
Abdelrahman G Salman, MD principal investigator
Ain Shams 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 Intravitreal injection (4mg/0.1ml), Superachoroidal injection (4 mg/0.1ml) and Suprachoroidal injection (2mg/0.1ml) in people with Safety and Efficacy, run by Azza Mohamed Ahmed Said 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 7 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 3 Sep 2019. 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 Azza MA Said, MD (2001006228992, dr_azza_22@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity (BCVA) (time frame: Six months after injection). 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 3 Sep 2019.