Diabetic Macular Edema
Conditions
Interventions
group A:At the baseline study visit, patients were intravitreal treatment with aflibercept (2mg/0.05ml)and DEX implant 0.7 mg (Week 0). Aflibercept 0.05 ml was administered at 4-week intervals (Week 4
group B:All patients received 3 doses of intravitreal aflibercept (2mg/0.05ml) administered at 4-week intervals (Week 0,Week 4, Week 8) and further IVR injections were administered as needed.
Sponsors
The Second Affiliated Hospital of Air Force Military Medical University,Chinese People’s Liberation Army
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 80 years, regardless of gender. 2. Diagnosed and untreated diabetic macular edema secondary to diabetes. 3. BCVA in the study eye, measured with the Early Treatment Diabetic Retinopathy Study method, was required to be between 34 and 73 letters (20/200-20/40). 4. central retinal thickness (CRT) of the study eye was required >=300µm by OCT. 5. The patient or his legal representative signed the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Macular edema caused by a cause other than diabetes, such as preretinal membrane, vitreoretinal traction, Retinal vein occlusion, Age-related Macular Degeneration, etc. 2. Patients has active proliferative diabetic retinopathy and requires treatment in the study eye. 3. Treatment with intravitreal anti-VEGF within the past 6 months. 4. Treatment with macular laser grid photocoagulation within the past 12 months. 5. Treatmented with intravitreal triamcinolone in the study eye at any time. 6. The study eye had undergone cataract surgery within the past six weeks. 7. Treatment with Panretinal Photocoagulation within the past 3 months. 8. A history of pars plana vitrectomy in the study eye or active uveitis. 9. IOP>35mmHg treated with 1 antiglaucoma medication. 10. Retinal detachment or macular hole and other fundus diseases in the study eye. 11. Chronic kidney failure requiring dialysis or a kidney transplant. 12. uncontrollable diabetes patients will be treated with intensive treatment within 3 months before study entry. 13. Any other conditions that the investigator considers to be preventing the patient from participating in the study (e.g. an unstable medical condition or serious illness that makes it difficult for the patient to complete the study). 14. Pregnancy or Lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best corrected visual acuity, BCVA; | — |
Secondary
| Measure | Time frame |
|---|---|
| Central retinal thickness, CRT;number of IVA;interval of IVA;DME grading; | — |
Countries
China
Contacts
Public ContactJing Han
The Second Affiliated Hospital of Air Force Military Medical University,Chinese People’s Liberation Army
Outcome results
None listed