Ischaemic Diabetic Macular Oedema MedDRA version: 14.1 Level: LLT Classification code 10057915 Term: Diabetic macular oedema System Organ Class: 10015919 - Eye disorders MedDRA version: 14.1 Level: PT Classification code 10012689 Term: Diabetic retinopathy System Organ Class: 10015919 - Eye disorders MedDRA version: 14.1 Level: PT Classification code 10012688 Term: Diabetic retinal oedema System Organ Class: 10015919 - Eye disorders MedDRA version: 14.1 Level: LLT Classification code 1005793
Conditions
Interventions
Trade Name: Lucentis
Product Name: Lucentis
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: Ranibizumab
CAS Number: SO1LA04
Concentration unit: mg/ml milligra
Sponsors
Moorfields Eye Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Age >= 18 years •Diagnosis of diabetes mellitus (type 1 or type 2) •Best corrected ETDRS visual acuity letter score at 4 metres (and approximate Snellen equivalent), between 20 and 70 letters (6/12 – 3/60) •Centre-involving diabetic macular oedema •Central macular thickness (CMT) = 300 µm on Spectralis SD-OCT •Enlarged foveal avascular zone (FAZ greatest linear dimension (GLD) =1000 µm) or a non-intact perifoveal capillary ring at the margin of the FAZ with FAZ GLD 700-1000 µm Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: •Blood pressure > 180/110 (systolic above 180 and diastolic above 110). •anti-VEGF treatment to the study eye within 4 months. •prior ocular surgery (including vitrectomy, cataract extraction) within 4 months. •history of treatment for DME at any time in the past 4 months (such as focal/grid macular photocoagulation, intravitreal or peribulbar corticosteroids, anti-VEGF drugs, or any other treatment). •history of panretinal photocoagulation (PRP) within 4 months or anticipated need for PRP in the 6 months following randomization. •aphakia. •Intraocular pressure >25 mmHg. •conditions/circumstances that preclude/significantly reduce the likelihood of response to therapy e.g. macular atrophy or exudative plaque.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Is the use of Lucentis therapy in patients with Diabetic Ischaemic Macular Oedema (DIME) safe? ;Secondary Objective: Is Lucentis therapy effective for patients with DIME as measured by visual function, vision-related quality of life and retinal thickness? ;Primary end point(s): Safety data will be gathered on the use of Lucentis therapy in patients with DIME by assessing: 1.Macular perfusion (FAZ greatest linear dimension (GLD) and degree of perifoveal capillary loss) 2.Retinal sensitivity (visual acuity, contrast sensitivity, and microperimetry). ;Timepoint(s) of evaluation of this end point: Each subject will be followed up to 12 months. This end points will be evaluated at 12 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Is Lucentis therapy effective for patients with DIME as measured by visual function (BCVA, contrast sensitivity, reading speed), vision-related quality of life and retinal thickness (OCT)? ;Timepoint(s) of evaluation of this end point: Each subject will be followed up to 12 months. These secondary end points will be evaluated at 12 months. | — |
Countries
United Kingdom
Contacts
Public ContactNatasha Ajraam Research Facilitator
Moorfields Eye Hospital NHS Foundation Trust
Outcome results
None listed