Retinal EdemaEarly Phase 1ResistantNCT04690608
Suprachoroidal Injection of Triamcinolone Acetonide in Resistant Diabetic Macular Edema, CRVO, Pseudophakic Cystoid Macular Edema and Diabetic Macular Edema Following Pars Plana Vitrectomy
A Early Phase 1 study testing Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1 in people with Retinal Edema, run by Tanta University at 1 site in Egypt.
Trial summary
Prospective interventional study on 60 eyes of resistant diabetic macular edema and central retinal vein occlusion that will receive suprachoroidal injection of Triamcinolone Acetonide (SCTA). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Retinal Edema
- What is being tested?
- Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 Feb 2025
- Phase
- Early Phase 1
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients fulfilling one or more of the following criteria will be considered to have resistant DME after at least 3 consecutive monthly anti VEGF injections in the previous 6 months:
- Central macular thickness greater than 300 μm by spectral-domain optical coherence tomography (SD-OCT).
- Reduction of retinal thickness by less than 10% of baseline retinal thickness.
- Suboptimal visual improvement (failure to gain at least 3 lines on the Snellen chart) and patients with recent onset central retinal vein occlusion less than 3 months.
Who cannot join
- Previous intraocular surgery (except cataract surgery done more than 6 months before the study).
- Coincident retinal pathology as choroidal neovascular membrane and age related macular degeneration.
- Previous laser photocoagulation.
- Intravitreal injection of triamcinolone acetonide.
- Prior ocular inflammation.
- The presence of retinal degeneration.
- Patients who didnot complete 6 months of follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Resistant Diabetic Macular Edema and Suprachoroidal Injection
Prospective interventional study on 60 eyes of resistant diabetic macular edema and central retinal vein occlusion that will receive suprachoroidal injection of Triamcinolone Acetonide (SCTA).
Read the detailed description
- Prospective non randomized interventional study on 60 eyes of 40 patients with previously diagnosed macular edema secondary to type 1 or 2 diabetes mellitus and 60 eyes with central retinal vein occlusion will be included.
- The study will be conducted from January 2021 to June 2021.
- For transition to suprachoroidal injection of Triamcinolone Acetone (TAAC) a diagnosis of resistant DME is required.
- Inclusion criteria:
Patients fulfilling one or more of the following criteria will be considered to have resistant diabetic macular edema (DME) after at least 3 consecutive monthly anti vascular endothelial growth factor (VEGF) injections in the previous 6 months: central macular thickness greater than 300 μm by spectral-domain optical coherence tomography (SD-OCT), reduction of retinal thickness by less than 10% of baseline retinal thickness, or suboptimal visual improvement (failure to gain at least 3 lines on the Snellen chart).
- The subjects included in the research will undergo the following tests and investigations:
- Visual acuity testing (uncorrected and best corrected).
- Intra ocular pressure (IOP) by applanation tonometry.
- Anterior segment examination by slit lamp
- Posterior segment examination by indirect ophthalmoscope and 78 D lens
- Spectral domain Optical coherence tomography (OCT).
- Ocular fundus photography and fluorescein angiography.
- Exclusion criteria will be:
- Previous intraocular surgery (except cataract surgery done more than 6 months before the study).
- Coincident retinal pathology as choroidal neovascular membrane and age related macular degeneration.
- Previous laser photocoagulation.
- Intravitreal injection of triamcinolone acetonide.
- Prior ocular inflammation.
- The presence of retinal degeneration.
- Patients who didnot complete 6 months of follow up
Injection technique:
Preoperative preparation:
- Preoperative control of (Diabetes Mellitus)DM is essential before injection.
- Informed consent was obtained according to the ethical committee after discussing extensively with each patient about the benefits, risks and possible side effects of the procedure .
- The patient was prepared by topical fluoroquinolone eye drops (Moxifloxacin hydrochloride 0.5% Vigamox ,Alcon, USA) 4 times daily for three days before injection.
All patients were dilated before suprachoroidal injection of Triamcinolone Acetonide (SCTA) and indirect ophthalmoscope was placed at hand to examine fundus after injection.
We used 30 gauge 1cc insulin syringe. Other dispensable included 24 gauge intravenous branula. Needle was withdrawn from branula and branula was cut in such a way that only 1000um of insulin syringe was exposed from the edge of branula. 0.1 ml (4 mg ) of Triamcinolone Acetonide (TAAC) will be injected.
Post operative care:
After the injection topical antibiotic drop was applied (Moxifloxacin hydrochloride 0.5% Vigamox, Alcon, USA) and the eye was patched for several hours.
After surgery patients were instructed to administer antibiotic drop four times daily for 3 days .
- Privacy of the patients must be guaranteed ,the data acquired from the participants will stay confidential through:
- Putting a code number to every patient, with hiding the patient's name.
- Photographing faces will not be needed.
- The results of the research will be only used in scientific aim.
- Any unexpected risks like subconjunctival hemorrhage, syncope, vitreous hemorrhage, retinal detachment and endophthalmitis appeared during the course of the research will be cleared to the participants and the ethical committee on time.
Medical care will be carried out to complications like syncope, subconjunctival hemorrhage and surgical treatment by pars plana vitrectomy will be done in case of occurrence of vitreous hemorrhage, retinal detachment or endophthalmitis.
- Conditions
- Retinal Edema
- Being tested
- Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1
- Keywords
- macular edema
- Medical subject headings
- Papilledema, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1Drug
Also called 30 gauge syringe with 24 gauge cannula
suprachoroidal injection of the drug in cases of resistant diabetic macular edema and central retinal vein occlusion
| Study group | Role | What they receive |
|---|---|---|
| resistant diabetic macular edema and central retinal vein occlusion | Experimental | * Prospective non randomized interventional study on 60 eyes of 40 patients with previously diagnosed macular edema secondary to type 1 or 2 diabetes mellitus will be included.
* The study will be conducted from January 2021 to June 2021.
* For transition to suprachoroidal injection of TAAC a diagnosis of resistant DME is required.
Cases with recent onset central retinal vein occlusion less than 2 months duration will be included Receives: Drug: Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of central macular thickness
Reduction of the central macular thickness below 300 um
Measured: 1 month
Secondary outcomes (1)
improved vision
Improvement of best corrected visual acuity
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 posted30 Dec 2020
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Retinal EdemaStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- cases of resistant diabetic macular edema and central retinal vein occlusion
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amin El Sayed Nawar, Tanta University
- Investigators
- Amin E Nawar, Lecturer, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04690608
- Sponsor's protocol ID
- 2412SS
- Acronym
- Resistant
- Status last verified
- Mar 2024
- First submitted
- 27 Dec 2020
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nawar AE. Efficacy of combined topical nepafenac 0.3% with suprachoroidal injection of triamcinolone acetonide using a modified custom needle in pseudopkakic cystoid macular edema. BMC Ophthalmol. 2025 Jul 3;25(1):350. doi: 10.1186/s12886-025-03972-6.
PubMed 40604486Nawar AE. Effectiveness of Suprachoroidal Injection of Triamcinolone Acetonide in Resistant Diabetic Macular Edema Using a Modified Microneedle. Clin Ophthalmol. 2022 Nov 21;16:3821-3831. doi: 10.2147/OPTH.S391319. eCollection 2022.
PubMed 36438589Nawar AE. Modified Microneedle for Suprachoroidal Injection of Triamcinolone Acetonide Combined with Intravitreal Injection of Ranibizumab in Branch Retinal Vein Occlusion Patients. Clin Ophthalmol. 2022 Apr 19;16:1139-1151. doi: 10.2147/OPTH.S361636. eCollection 2022.
PubMed 35469288
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resistant Diabetic Macular Edema and Suprachoroidal Injection
- ClinicalTrials.gov ID
- NCT04690608
- Acronym / sponsor ID
- Resistant / 2412SS
- Conditions
- Retinal Edema
- Keywords
- macular edema
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 30 Dec 2020 (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.
Prospective interventional study on 60 eyes of resistant diabetic macular edema and central retinal vein occlusion that will receive suprachoroidal injection of Triamcinolone Acetonide (SCTA).
Detailed description
- Prospective non randomized interventional study on 60 eyes of 40 patients with previously diagnosed macular edema secondary to type 1 or 2 diabetes mellitus and 60 eyes with central retinal vein occlusion will be included.
- The study will be conducted from January 2021 to June 2021.
- For transition to suprachoroidal injection of Triamcinolone Acetone (TAAC) a diagnosis of resistant DME is required.
- Inclusion criteria:
Patients fulfilling one or more of the following criteria will be considered to have resistant diabetic macular edema (DME) after at least 3 consecutive monthly anti vascular endothelial growth factor (VEGF) injections in the previous 6 months: central macular thickness greater than 300 μm by spectral-domain optical coherence tomography (SD-OCT), reduction of retinal thickness by less than 10% of baseline retinal thickness, or suboptimal visual improvement (failure to gain at least 3 lines on the Snellen chart).
- The subjects included in the research will undergo the following tests and investigations:
- Visual acuity testing (uncorrected and best corrected).
- Intra ocular pressure (IOP) by applanation tonometry.
- Anterior segment examination by slit lamp
- Posterior segment examination by indirect ophthalmoscope and 78 D lens
- Spectral domain Optical coherence tomography (OCT).
- Ocular fundus photography and fluorescein angiography.
- Exclusion criteria will be:
- Previous intraocular surgery (except cataract surgery done more than 6 months before the study).
- Coincident retinal pathology as choroidal neovascular membrane and age related macular degeneration.
- Previous laser photocoagulation.
- Intravitreal injection of triamcinolone acetonide.
- Prior ocular inflammation.
- The presence of retinal degeneration.
- Patients who didnot complete 6 months of follow up
Injection technique:
Preoperative preparation:
- Preoperative control of (Diabetes Mellitus)DM is essential before injection.
- Informed consent was obtained according to the ethical committee after discussing extensively with each patient about the benefits, risks and possible side effects of the procedure .
- The patient was prepared by topical fluoroquinolone eye drops (Moxifloxacin hydrochloride 0.5% Vigamox ,Alcon, USA) 4 times daily for three days before injection.
All patients were dilated before suprachoroidal injection of Triamcinolone Acetonide (SCTA) and indirect ophthalmoscope was placed at hand to examine fundus after injection.
We used 30 gauge 1cc insulin syringe. Other dispensable included 24 gauge intravenous branula. Needle was withdrawn from branula and branula was cut in such a way that only 1000um of insulin syringe was exposed from the edge of branula. 0.1 ml (4 mg ) of Triamcinolone Acetonide (TAAC) will be injected.
Post operative care:
After the injection topical antibiotic drop was applied (Moxifloxacin hydrochloride 0.5% Vigamox, Alcon, USA) and the eye was patched for several hours.
After surgery patients were instructed to administer antibiotic drop four times daily for 3 days .
- Privacy of the patients must be guaranteed ,the data acquired from the participants will stay confidential through:
- Putting a code number to every patient, with hiding the patient's name.
- Photographing faces will not be needed.
- The results of the research will be only used in scientific aim.
- Any unexpected risks like subconjunctival hemorrhage, syncope, vitreous hemorrhage, retinal detachment and endophthalmitis appeared during the course of the research will be cleared to the participants and the ethical committee on time.
Medical care will be carried out to complications like syncope, subconjunctival hemorrhage and surgical treatment by pars plana vitrectomy will be done in case of occurrence of vitreous hemorrhage, retinal detachment or endophthalmitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- cases of resistant diabetic macular edema and central retinal vein occlusion
| Arm | Type | Receives |
|---|---|---|
| resistant diabetic macular edema and central retinal vein occlusion | Experimental | Drug: Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1* Prospective non randomized interventional study on 60 eyes of 40 patients with previously diagnosed macular edema secondary to type 1 or 2 diabetes mellitus will be included. * The study will be conducted from January 2021 to June 2021. * For transition to suprachoroidal injection of TAAC a diagnosis of resistant DME is required. Cases with recent onset central retinal vein occlusion less than 2 months duration will be included |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients fulfilling one or more of the following criteria will be considered to have resistant DME after at least 3 consecutive monthly anti VEGF injections in the previous 6 months:
- Central macular thickness greater than 300 μm by spectral-domain optical coherence tomography (SD-OCT).
- Reduction of retinal thickness by less than 10% of baseline retinal thickness.
- Suboptimal visual improvement (failure to gain at least 3 lines on the Snellen chart) and patients with recent onset central retinal vein occlusion less than 3 months.
Key exclusion criteria (7 listed)
- Previous intraocular surgery (except cataract surgery done more than 6 months before the study).
- Coincident retinal pathology as choroidal neovascular membrane and age related macular degeneration.
- Previous laser photocoagulation.
- Intravitreal injection of triamcinolone acetonide.
- Prior ocular inflammation.
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 |
|---|---|---|
| Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1Also: 30 gauge syringe with 24 gauge cannulasuprachoroidal injection of the drug in cases of resistant diabetic macular edema and central retinal vein occlusion | Drug | resistant diabetic macular edema and central retinal vein occlusion |
Primary outcome
Improvement of central macular thickness
Time frame: 1 month
Reduction of the central macular thickness below 300 um
1 secondary outcome
improved vision
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Derived from this study: PubMed 40604486Nawar AE. Efficacy of combined topical nepafenac 0.3% with suprachoroidal injection of triamcinolone acetonide using a modified custom needle in pseudopkakic cystoid macular edema. BMC Ophthalmol. 2025 Jul 3;25(1):350. doi: 10.1186/s12886-025-03972-6.
- Derived from this study: PubMed 36438589Nawar AE. Effectiveness of Suprachoroidal Injection of Triamcinolone Acetonide in Resistant Diabetic Macular Edema Using a Modified Microneedle. Clin Ophthalmol. 2022 Nov 21;16:3821-3831. doi: 10.2147/OPTH.S391319. eCollection 2022.
- Derived from this study: PubMed 35469288Nawar AE. Modified Microneedle for Suprachoroidal Injection of Triamcinolone Acetonide Combined with Intravitreal Injection of Ranibizumab in Branch Retinal Vein Occlusion Patients. Clin Ophthalmol. 2022 Apr 19;16:1139-1151. doi: 10.2147/OPTH.S361636. eCollection 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.
Amin E Nawar, Lecturer principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1 in people with Retinal Edema, run by Tanta 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 4 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 5 Mar 2024. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Amin E Nawar, Lecturer (00201140095692, nawar20012002@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of central macular thickness (time frame: 1 month). 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 NCT04690608, which also lists 3 linked publications.
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 5 Mar 2024.