An interventional study of Custom suorachoroidal needle in Diabetic Macular Edema, Cystoid Macular Edema, Chorodial Neovascularzation, Posterior Uveitis, sponsored by Marashi Eye Clinic. Status unknown at 1 site in Syrian Arab Republic. Open to participants aged 20 Years to 99 Years. Per ClinicalTrials.gov, last updated 2018-10-29.
Sponsored by Marashi Eye Clinic · Not applicable, Interventional, and Treatment
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.
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.
756 studies on the registry are indexed under Macular Edema; 65 are open to participants now.
This study's planned enrollment of 100 is above the median of 56 across 584 interventional studies indexed under Macular Edema.
Browse Macular Edema studies →Marashi Eye Clinic is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A custom made 30 gauge needle offering 1000 micron penetration of the sclera at the parsplana
Procedure: Custom suorachoroidal needle
Custom made Supra Choroidal Space needle
Proportion of patients achieved visual acuity improvement
To measure best corrected visual acuity using using Snellen chart or equivalent
Time frame: 12 weeks
Amount of Central macular thickness reduction in microns
Using optical coherence tomography in monthly bases to measure central retinal thickness
Time frame: 12 weeks
Proportion of eyes with Increased intraocular pressure
To measure intraocular pressure using Goldmann applanation tonometer
Time frame: 12 weeks
Started Jul 2018 (actual). Primary completion is estimated for Aug 2019, 13 months after the start.
Of 46 non-industry interventional studies with no phase under Macular Edema, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 42. This study's planned 13 months is below that.
Counting every sponsor, half of 50 studies reached it within 21 months; a quarter within 9 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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