Diabetic Maculopathy: Clinically significant macular oedema To understand the effects of intravitreal triamcinolone (IVTA) in the treatment of clinically significant macular edema (CSME) in diabetics who have concurrent cataract which requires intervention. MedDRA version: 8.1 Level: LLT Classification code 10057915 Term: Diabetic macular oedema
Conditions
Interventions
Trade Name: Kenalog
Product Name: Kenalog
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: TRIAMCINOLONE ACETONIDE
CAS
Sponsors
Moorfields Eye Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with Type 1 or Type 2 diabetes mellitus diagnosed according to the 1999 WHO standard 2. Patients with cataract sufficient in an eye to either cause visual symptoms such as reduced visual acuity, glare, material index myopia, or monocular polyopia, or sufficient to impair fundus visualisation for macular laser treatment of clinically significant macular edema (CSME) as defined by the Early Treatment Diabetic Retinopathy Study (ETDRS) 14 3. Patients who have persistent CSMO despite previous laser treatment and have concurrent visual impairment considered partially due to cataract. 4. Patients who have moderate, severe non proliferative diabetic retinopathy, and treated proliferative diabetic retinopathy as defined by a clinical modification 15 of the ETDRS final retinopathy severity scale 16 . 5. Optical Coherence Tomography III (OCT) measurements of >300 micron at central subfield of fast macula map pre-operatively at the time of listing. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patients with no CSME 2. High-risk proliferative retinopathy as defined by the Diabetic Retinopathy Study (DRS) . Patients in whom high-risk proliferative retinopathy had regressed at least 4 months following appropriate laser treatment were considered eligible. 3. Diabetes associated with specific genetic syndromes (type A insulin resistance); induced by drugs, chemicals, or endocrinopathies; or secondary to pancreatic tumour or pancreatectomy. 4. Coexistent ocular disease likely to modify visual acuity, for example age-related macular degeneration, amblyopia, retinal venous occlusion. 5. Coexistent disease likely to significantly affect retinopathy progression, for example severe carotid occlusive disease, high myopia, glaucoma. Patients with renal dysfunction are however, included in the study, as dictated by the need to recruit sufficient patients with more severe retinopathy, in whom some renal impairment was common. 6. Patients with coexistent disease likely to respond poorly to side effects of intravitreal triamcinalone including glaucoma, ocular hypertension, steroid responders. 7. Prior intraocular surgery to either eye. 8. Complicated cataract surgery.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To understand the effects of intravitreal triamcinolone (IVTA) in the treatment of clinically significant macular edema (CSME) in diabetics who have concurrent cataract which requires intervention. ;Secondary Objective: ;Primary end point(s): Resolution of CSME at 12 months following cataract surgery with intravitreal triamcinolone injection. | — |
Countries
United Kingdom
Outcome results
None listed