Diabetic Macular Edema, Cystoid Macular Edema, Chorodial Neovascularzation, Posterior UveitisNCT03606733
Suprachoroidal Injection of Triamcinolone Acetonide Using Custom Made Needle to Treat Retinal Disorders
A study testing Custom suorachoroidal needle in people with Diabetic Macular Edema, Cystoid Macular Edema, Chorodial Neovascularzation, Posterior Uveitis, run by Marashi Eye Clinic at 1 site in Syria.
Trial summary
Injection in the Suprachoroidal space has potential of increasing the efficacy of the drug upto six times with direct effect on retinal tissues sparing the crystalline lens and trabecular meshwork. Read more about this study
- Who is it for?
- Ages 20 to 99 years
- Conditions the study is for
- Diabetic Macular Edema, Cystoid Macular Edema, Chorodial Neovascularzation, Posterior Uveitis
- What is being tested?
- Custom suorachoroidal needle
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSyria
- Study dates
- 1 Jul 2018to 1 Sep 2019
- 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 20 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 years and older
- Patients with macular edema or degeneration from various pathologies
- Central macular thickness more than 250 microns
- Patients who are able to come for all follow-up
Who cannot join
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
- Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis
Trial locations and contacts
1 site in 1 country.
Syria1 site, 1 recruiting
- Recruiting
Marashi Eye Clinic
Aleppo, 2241511
Ameen Marashi, MD, 963212241511, ameenmarashi@hotmail.com
About this study
Official title: Suprachoroidal Injection of Triamcinolone Acetonide Using Custom Made Needle to Treat Macular Diseases and Non Infectious Posterior Uveitis
Injection in the Suprachoroidal space has potential of increasing the efficacy of the drug upto six times with direct effect on retinal tissues sparing the crystalline lens and trabecular meshwork.
Read the detailed description
A custom made 30 gauge needle offering 1000 micron penetration of the sclera at the parsplana with the help of gentle pressure on the sclera will help to inject medication such as triamcinilone or VEGF blockade agents (Ziv aflibercept or Bevacizumab) in the potential Suprachoroidal space which offers direct effect of injected drug on the retina and choroid sparing both crystalline lens, trabecular meshwork and other ocular tissues, hence improving efficacy of the drug upto six times and reduce potential complications such as cataract and glaucoma.
- Conditions
- Diabetic Macular Edema, Cystoid Macular Edema, Chorodial Neovascularzation, Posterior Uveitis
- Being tested
- Custom suorachoroidal needle
- Medical subject headings
- Macular Edema, Uveitis, Posterior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom suorachoroidal needleProcedure or surgery
Custom made Supra Choroidal Space needle
| Study group | Role | What they receive |
|---|---|---|
| A custom made Suprachoroidal needle for macular diseases | Experimental | A custom made 30 gauge needle offering 1000 micron penetration of the sclera at the parsplana Receives: Procedure: Custom suorachoroidal needle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieved visual acuity improvement
To measure best corrected visual acuity using using Snellen chart or equivalent
Measured: 12 weeks
Secondary outcomes (2)
Amount of Central macular thickness reduction in microns
Using optical coherence tomography in monthly bases to measure central retinal thickness
Measured: 12 weeks
Proportion of eyes with Increased intraocular pressure
To measure intraocular pressure using Goldmann applanation tonometer
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2018
- Study start1 Jul 2018
- Primary completion1 Aug 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
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 Macular Edema, Cystoid Macular Edema, Chorodial Neovascularzation, Posterior UveitisStudies 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
- Model description
- Injection of triamcinilone or/ and VEGF blockade agents in the Supra Choroidal Space
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marashi Eye Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ameen Marashi, Marashi Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03606733
- Sponsor's protocol ID
- SCS
- Status last verified
- Oct 2018
- First submitted
- 22 Jul 2018
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Marashi A. Treating macular edema secondary to retinal vein occlusion with suprachoroidal injection of triamcinolone acetonide using custom made needle. Adv Ophthalmol Vis Syst. 2018;8(5):277-281. DOI: 10.15406/aovs.2018.08.00321
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suprachoroidal Injection of Triamcinolone Acetonide Using Custom Made Needle to Treat Macular Diseases and Non Infectious Posterior Uveitis
- ClinicalTrials.gov ID
- NCT03606733
- Acronym / sponsor ID
- SCS
- Conditions
- Diabetic Macular Edema, Cystoid Macular Edema, Chorodial Neovascularzation, Posterior Uveitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Marashi Eye ClinicUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Aug 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 31 Jul 2018 (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.
Injection in the Suprachoroidal space has potential of increasing the efficacy of the drug upto six times with direct effect on retinal tissues sparing the crystalline lens and trabecular meshwork.
Detailed description
A custom made 30 gauge needle offering 1000 micron penetration of the sclera at the parsplana with the help of gentle pressure on the sclera will help to inject medication such as triamcinilone or VEGF blockade agents (Ziv aflibercept or Bevacizumab) in the potential Suprachoroidal space which offers direct effect of injected drug on the retina and choroid sparing both crystalline lens, trabecular meshwork and other ocular tissues, hence improving efficacy of the drug upto six times and reduce potential complications such as cataract and glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Injection of triamcinilone or/ and VEGF blockade agents in the Supra Choroidal Space
| Arm | Type | Receives |
|---|---|---|
| A custom made Suprachoroidal needle for macular diseases | Experimental | Procedure: Custom suorachoroidal needleA custom made 30 gauge needle offering 1000 micron penetration of the sclera at the parsplana |
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 20 years and older
- Patients with macular edema or degeneration from various pathologies
- Central macular thickness more than 250 microns
- Patients who are able to come for all follow-up
Key exclusion criteria (4 listed)
- Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
- Myocardial infarction, other acute cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 4 months prior to randomization
- For women of child-bearing potential: pregnant or lactating or intending to become pregnant within the next 3 years.
- Exam evidence of severe external ocular infection, including conjunctivitis, chalazion, or substantial blepharitis
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 |
|---|---|---|
| Custom suorachoroidal needleCustom made Supra Choroidal Space needle | Procedure or surgery | A custom made Suprachoroidal needle for macular diseases |
Primary outcome
Proportion of patients achieved visual acuity improvement
Time frame: 12 weeks
To measure best corrected visual acuity using using Snellen chart or equivalent
2 secondary outcomes
Amount of Central macular thickness reduction in microns
Time frame: 12 weeks
Proportion of eyes with Increased intraocular pressure
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- BackgroundMarashi A. Treating macular edema secondary to retinal vein occlusion with suprachoroidal injection of triamcinolone acetonide using custom made needle. Adv Ophthalmol Vis Syst. 2018;8(5):277-281. DOI: 10.15406/aovs.2018.08.00321
- Treating macular edema secondary to retinal vein occlusion with suprachoroidal injection of triamcinolone acetonide using custom made needleLink provided by the sponsor.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom suorachoroidal needle in people with Diabetic Macular Edema, Cystoid Macular Edema, Chorodial Neovascularzation, Posterior Uveitis, run by Marashi Eye Clinic at 1 site in Syria.
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 4 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 29 Oct 2018. 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 Syria. 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 Ameen Marashi (963937785557, ameenmarashi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieved visual acuity improvement (time frame: 12 weeks). 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 NCT03606733, 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 29 Oct 2018.