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Diabete Type 2Phase 2/3NCT05413330

Corticosteroid Injection Combined With Cataract Surgery in Diabetic Eyes.

A Phase 2/3 study testing Triamcinolone Acetonide in people with Diabete Type 2 and Cataract, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators aim in this study to investigate the effect of intravitreal triamcinolone acetonide injection on the development of macular edema and the progression of diabetic retinopathy. Whether this injection hastens cataract surgery results or not. Read more about this study

Who is it for?
Ages 19 to 49 years
Conditions the study is for
Diabete Type 2, Cataract, Triamcinolone Acetonide
What is being tested?
Triamcinolone Acetonide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
73 participants
Where
1 siteSyria
Study dates
12 Sep 2020to 29 Mar 2022
Phase
Phase 2/3
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 19 to 49 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • ● A history of diabetes mellitus DM type II that is well-confirmed by an endocrinologist.
  • Senile cataract that is causing visual disturbance as demonstrated by clinical examination.
  • CDVA of no more than 20/ 40, finger count and hand movement vision are included. Too.
  • Diabetic retinopathy that falls in one of the following categories according to the International Clinical Diabetic Retinopathy Disease Severity Scale: No DR- mild NPDR- moderate NPDR.
  • A healthy-looking central macula, or Clinically Significant Macular Edema (CSME), or edema that is apparent on Fundus Fluorescent Angiography (FFA) or OCT, as well as a treatment-resistant diabetic macular edema in the past 24 months or microaneurysms at foveal avascular zone (FAZ) borders not amenable to laser therapy.
  • Both sexes, Age 18 years or older.
  • One eye per patient will be included.
  • The surgery will be performed by the same surgeon and the samIOL design will be used.

Who cannot join

  • • A history of diabetes mellitus DM type I that is well-confirmed by an endocrinologist or no history of DM.
  • CDVA that is better than 20/40.
  • functionally monocular patient as a result of moderate to severe visual impairment in the contralateral eye, as per the definition of the International Statistical Classification of Diseases and Related Health Problems, 10th revision (6).
  • The presence of pathologies other than diabetic retinopathy and cataract that may justify visual acuity decline (e.g. corneal disease, age related macular degeneration, macular hole, etc…).
  • patients will be excluded if they had an increased risk for developing CME in the study eye because of a complication during the current or previous intraocular surgery, intraocular inflammation or uveitis, retinal vein occlusion, or macular pathology that might influence visual function, other than diabetic macular edema.
  • Patients with pseudoexfoliation syndrome, Fuchs endothelial dystrophy, or post-traumatic cataract in the study eye.
Show all 16Show fewer
  • Diabetic retinopathy that falls in one of the following categories according to the International Clinical Diabetic Retinopathy Disease Severity Scale: severe NPDR, proliferative DR, or vitreous hemorrhage requiring pan-retinal photocoagulation or vitrectomy.
  • Patients who used topical NSAIDs, topical or systemic corticosteroids before surgery.
  • patients who received an intravitreal injection with any kind of anti-VEGF in the study eye in the previous 6 weeks, or an intraocular or periocular corticosteroid injection in the previous 3 months.
  • patients who received PRP during the past 3 months.
  • Contraindications for any of the investigated drugs, particularly patients with glaucoma, IOP of 21mm Hg or higher, previous steroid-induced IOP elevation, or ganglion cell/ RNFL complex injury on OCT image.
  • History of steroid hypersensitivity.
  • Patients who are taking steroids PO with a total dosage of more than 5 mg/ day.
  • Pregnant and breastfeeding ladies.
  • Previous surgery on the study eye.
  • systemic bleeding in the previous 3 months, major systemic surgery in the previous 3 months, or a recent or recurrent cerebrovascular accident, myocardial infarction, or thromboembolic event.

Trial locations and contacts

1 site in 1 country.

Syria1 site

  • Damascus University

    Damascus, 00000

Other trials in Syria

About this study

Official title: Combined Phacoemulsification Surgery and Intravitreal Triamcinolone Injection Versus Stand-alone Surgery in Patients With Type 2 Diabetes: A Randomized Controlled Trial

The investigators aim in this study to investigate the effect of intravitreal triamcinolone acetonide injection on the development of macular edema and the progression of diabetic retinopathy. Whether this injection hastens cataract surgery results or not. The investigators will categorize the participants into two groups: the case group who will receive the injection at the end of the surgery, and the control group who will have routine cataract surgery with no extra injections.

Read the detailed description

Cataract and diabetic retinopathy (DR) represent two of the top five leading causes of global impaired vision and blindness according to the WHO. Higher incidence and faster cataract progression are well-established in diabetic patients, especially those with higher glycated hemoglobin values. Further, it is estimated that up to 20% of all cataract surgery is performed on diabetic patients. The investigators aim in this study to contribute to investigating the efficacy of triamcinolone acetonide injection at the end of phacoemulsification surgery in patients with type 2 diabetes in comparison with the standard phacoemulsification surgery: whether it blunts the initiation as well as the progression of diabetic macular edema and diabetic retinopathy, and improves visual outcomes. Besides, The investigators aim to evaluate the consequences and safety of the injection.

Being tested
Triamcinolone Acetonide
Keywords
diabetes, phacoemulsification, intravitreal, triamcinolone acetonide, diabetic retinopathy, central subfield macular thickness, CSMT, CDVA, IOP
Medical subject headings
Diabetes Mellitus, Type 2, Cataract, Diabetes Mellitus, Diabetic Retinopathy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Triamcinolone AcetonideDrug

    Also called Kenalog

    Intravitreal injection of 4 mg/0.1 mL preservative-free triamcinolone acetonide at the end of phacoemulsification surgery will be injected at 3.5 mm inferolateral and posterior to the limbus.

Study groups in NCT05413330
Study groupRoleWhat they receive
IVTA groupExperimentalPatients will receive an intravitreal injection of 4 mg/0.1 mL preservative-free triamcinolone acetonide at the end of surgery.
Receives: Drug: Triamcinolone Acetonide
No injection groupNo interventionPatients will receive no additional treatment to the standard phacoemulsification surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in central subfield mean macular thickness as a measurement of efficacy

    The primary endpoint is the change in central subfield mean macular thickness in the 1 mm area (central subfield macular thickness, CSMT) as compared to baseline within the first 6 months postoperatively.

    Measured: T0_ 1 month- T1_ 3 months- T2_ 6 months postoperatively]

  2. Change in diabetic retinopathy grade as a measurement of efficacy

    The primary endpoint is the change in diabetic retinopathy grade as compared to baseline within the first 6 months postoperatively.

    Measured: T0: 1 month- T2: 3 months- T3: 6 months postoperatively

Secondary outcomes (3)

  1. Change in corrected distance visual acuity CDVA as a measurement of efficacy

    CDVA measurements will be taken in metres then converted to Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts (logMAR).

    Measured: _1 week- T1_ 1 month- T2_ 3 months- T3_ 6 months postoperatively

  2. ntraocular pressure (IOP) as a measurement of safety

    IOP (in mmHg) will be measured by Goldmann applanation tonometry

    Measured: T0: 1 week- T1: 1 month- T2: 3 months- T3: 6 months postoperatively

  3. No. of subjects with Adverse Events as a measurement of safety

    An adverse event (AE) is defined as any undesirable experience occurring to a subject during the study, whether or not considered related to the investigational product. All adverse events reported spontaneously by the subject or observed by the principal investigator or his staff will be recorded. Endophthalmitis in particular will be recorded.

    Measured: T0: 1 week- T1: 1 month-T2: 3 months- T3: 6 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2022
  2. Study start12 Sep 2020
  3. Primary completion5 Jan 2022
  4. Study completion29 Mar 2022

Resources

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 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective randomized single-blinded clinical trial
Masking
Single blind
Who is masked
Participant
Enrolment
73 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05413330
Sponsor's protocol ID
UDMS-Opthal-01-2022
Status last verified
Apr 2023
First submitted
7 Jun 2022
Last updated
26 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Kim SY, Yang J, Lee YC, Park YH. Effect of a single intraoperative sub-Tenon injection of triamcinolone acetonide on the progression of diabetic retinopathy and visual outcomes after cataract surgery. J Cataract Refract Surg. 2008 May;34(5):823-6. doi: 10.1016/j.jcrs.2008.01.018.

    PubMed 18471640

  • Chung J, Kim MY, Kim HS, Yoo JS, Lee YC. Effect of cataract surgery on the progression of diabetic retinopathy. J Cataract Refract Surg. 2002 Apr;28(4):626-30. doi: 10.1016/s0886-3350(01)01142-7.

    PubMed 11955902

  • Lundstrom M, Barry P, Henry Y, Rosen P, Stenevi U. Visual outcome of cataract surgery; study from the European Registry of Quality Outcomes for Cataract and Refractive Surgery. J Cataract Refract Surg. 2013 May;39(5):673-9. doi: 10.1016/j.jcrs.2012.11.026. Epub 2013 Mar 14.

    PubMed 23499065

  • Simons RWP, Wielders LHP, Nuijts RMMA, Veldhuizen CA, van den Biggelaar FJHM, Winkens B, Schouten JSAG, Dirksen CD; ESCRS PREMED Study Group. Economic evaluation of prevention of cystoid macular edema after cataract surgery in diabetic patients: ESCRS PREMED study report 6. J Cataract Refract Surg. 2022 May 1;48(5):555-563. doi: 10.1097/j.jcrs.0000000000000785.

    PubMed 34417781

  • Mittra RA, Borrillo JL, Dev S, Mieler WF, Koenig SB. Retinopathy progression and visual outcomes after phacoemulsification in patients with diabetes mellitus. Arch Ophthalmol. 2000 Jul;118(7):912-7.

    PubMed 10900103

  • Mentes J, Erakgun T, Afrashi F, Kerci G. Incidence of cystoid macular edema after uncomplicated phacoemulsification. Ophthalmologica. 2003 Nov-Dec;217(6):408-12. doi: 10.1159/000073070.

    PubMed 14573973

  • Lee R, Wong TY, Sabanayagam C. Epidemiology of diabetic retinopathy, diabetic macular edema and related vision loss. Eye Vis (Lond). 2015 Sep 30;2:17. doi: 10.1186/s40662-015-0026-2. eCollection 2015.

    PubMed 26605370

  • Diabetic Retinopathy Clinical Research Network; Elman MJ, Aiello LP, Beck RW, Bressler NM, Bressler SB, Edwards AR, Ferris FL 3rd, Friedman SM, Glassman AR, Miller KM, Scott IU, Stockdale CR, Sun JK. Randomized trial evaluating ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology. 2010 Jun;117(6):1064-1077.e35. doi: 10.1016/j.ophtha.2010.02.031. Epub 2010 Apr 28.

    PubMed 20427088

  • Eriksson U, Alm A, Bjarnhall G, Granstam E, Matsson AW. Macular edema and visual outcome following cataract surgery in patients with diabetic retinopathy and controls. Graefes Arch Clin Exp Ophthalmol. 2011 Mar;249(3):349-59. doi: 10.1007/s00417-010-1484-9. Epub 2010 Sep 9.

    PubMed 20827486

  • Wielders LHP, Schouten JSAG, Winkens B, van den Biggelaar FJHM, Veldhuizen CA, Findl O, Murta JCN, Goslings WRO, Tassignon MJ, Joosse MV, Henry YP, Rulo AHF, Guell JL, Amon M, Kohnen T, Nuijts RMMA; ESCRS PREMED Study Group. European multicenter trial of the prevention of cystoid macular edema after cataract surgery in nondiabetics: ESCRS PREMED study report 1. J Cataract Refract Surg. 2018 Apr;44(4):429-439. doi: 10.1016/j.jcrs.2018.01.029.

    PubMed 29778106

  • Zaher Addeen S, Shaddoud I. Combined phacoemulsification surgery and intravitreal triamcinolone injection versus stand-alone surgery in patients with type 2 diabetes: a prospective randomized trial. BMC Ophthalmol. 2022 Nov 19;22(1):445. doi: 10.1186/s12886-022-02676-5.

    PubMed 36401233

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Triamcinolone Acetonide in people with Diabete Type 2 and Cataract, run by Damascus University 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 8 inclusion and 16 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: finished, as of the sponsor's last update on 26 Apr 2023. 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in central subfield mean macular thickness as a measurement of efficacy (time frame: T0_ 1 month- T1_ 3 months- T2_ 6 months postoperatively]). The study lists 2 primary outcomes in all. 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 NCT05413330, which also lists 11 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 26 Apr 2023.

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