Clinical trial NCT04690608: Suprachoroidal Injection of Triamcinolone Acetonide in Resistant Diabetic Macular Edema, CRVO, Pseudophakic Cystoid Macular Edema and Diabetic Macular Edema Following Pars Plana Vitrectomy
Official title: Resistant Diabetic Macular Edema and Suprachoroidal Injection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Retinal Edema
Keywords: macular edema
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: cases of resistant diabetic macular edema and central retinal vein occlusion
Primary purpose: TREATMENT

Brief 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).

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:

  1. Visual acuity testing (uncorrected and best corrected).
  2. Intra ocular pressure (IOP) by applanation tonometry.
  3. Anterior segment examination by slit lamp
  4. Posterior segment examination by indirect ophthalmoscope and 78 D lens
  5. Spectral domain Optical coherence tomography (OCT).
  6. Ocular fundus photography and fluorescein angiography.
* Exclusion criteria will be:

  1. Previous intraocular surgery (except cataract surgery done more than 6 months before the study).
  2. Coincident retinal pathology as choroidal neovascular membrane and age related macular degeneration.
  3. Previous laser photocoagulation.
  4. Intravitreal injection of triamcinolone acetonide.
  5. Prior ocular inflammation.
  6. The presence of retinal degeneration.
  7. Patients who didnot complete 6 months of follow up

Injection technique:

Preoperative preparation:

1. Preoperative control of (Diabetes Mellitus)DM is essential before injection.
2. 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 .
3. 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:

  1. Putting a code number to every patient, with hiding the patient's name.
  2. Photographing faces will not be needed.
  3. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Improvement of central macular thickness
timeFrame: 1 month
Secondary outcomes:
measure: improved vision
timeFrame: 3 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Tanta University
state: El Gharbia
Study officials:
affiliation: Tanta University
name: Amin E Nawar, Lecturer
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nawar 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.