Diabetic macular edema
Conditions
Interventions
Group 1: Repeated SHAM
Group 2: LASER followed by SHAM
Group 3: Repeated LASER.
All participants will receive four intravitreal anti-VEGF injections during the first period (week 0 till 19) and dependant on the study arm zero, one or two lasertreatments.
Sponsors
The Rotterdam Eye Hospital /
Rotterdam Ophthalmic Institute
PO Box 70030, NL-3000 LM Rotterdam
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age ¡Ý 18 years; 2. Able to read and sign the written informed consent; 3. Diagnosis of DME, based on ETDRS criteria and confirmed by macular edema on optical coherence tomography (OCT, Heidelberg Spectralis), defined as CFT ¡Ý 340 micron (see Section 7.1 for argumentation for chosen cut-off value); 4. VA loss due to DME, with VA being between 45 and 85 letters as measured on ETDRS chart (Snellen decimal equivalent: 0.08 ¡§C 0.63); 5. If both eyes are eligible, the eye with the highest CFT will be selected as the study eye. If both eyes have equal CFT, the eye with the most recent record of presence of DME will be selected as the study eye. The fellow eye will receive treatment according to the current standard of care at the investigator's discretion.
Exclusion criteria
Exclusion criteria: 1. Previous laser photocoagulation therapy within the last 6 months; 2. Previous anti-VEGF therapy (Avastin, Lucentis, Eylea, or any investigational anti-VEGF drug) within the last 3 months; 3. Previous subtenon's or intravitreal triamcinolone injection within the last 6 months; 4. Steroid implants of any kind within the last 3 years; 5. Macular ischemia confirmed by fluorescein angiography (FA); 6. Vitreoretinal traction or epiretinal membranes with the potential of macular structural damage and function loss, confirmed by OCT; 7. Other eye conditions affecting VA prognosis, including pre-existent (deep) amblyopia; 8. Any ocular surgery/intervention within last three months before enrollment; 9. Any ocular surgery/intervention anticipated during the course of the study; 10. Ocular opacities hampering adequate imaging of the posterior pole; 11. Poor control of DM with glycated hemoglobin (HbA1c) of ¡Ý 86% in last 6 months; 12. Allergy to fluorescein or anti-VEGF, or any of its preservatives; 13. Pregnancy; 14. Non-Caucasian or Asian descent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of treatment failures at 72 weeks, with treatment failure defined at 24 weeks as 50 micron increase in CFT, irrespective of VA, compared to week 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Demographic data at baseline; 2. ETDRS DRP grading; 3. Correlation of response rate to baseline VA, baseline CFT, baseline DRP grading, DM duration, DM control, prior DME therapy; 4. DME characteristics on OCT (diffuse or focal edema, size cystoids spaces); 5. Proportion of patients gaining 0-5, 5-10, 10-15 and >15 letters at 24 weeks and every subsequent visit until 72 weeks (compared to baseline); 6. Proportion of patients losing letters at 24 weeks compared to baseline; 7. Median time to treatment failure overall and for each treatment group; 8. Maximal VA during follow-up; 9. VA improvement during follow-up; 10. Maximal reduction in CFT; 11. Change in DRP grading; 12. Control of DM measured through HbA1c; 13. Safety parameters: proportion of (serious) adverse events, changes in intraocular pressure, progression of cataract and degree of DRP. In addition to safety data derived from this study, solicited safety data will be obtained from participants who continue observation in the cohort extension after withdrawal or treatment failure; 14. Change in the following questionnaires (from baseline through final follow-up visit): A. VFQ-25; B. SF-36; C. EQ-5D. | — |
Contacts
Public ContactT. Missotten
Oogziekenhuis Rotterdam, Schiedamsevest 180,
Outcome results
None listed