idiopathic epiretinal membrane
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients volunteered for the study and signed informed consent; 2. Aged 18 to 75 years old (including the age of 18 and 75); 3. In the 12 months prior to screening visit, the research eye was diagnosed with idiopathic macular membrane (IMEM) causing visual impairment; 4. BCVA in screening and baseline visit: BCVA of the research eye is no less than 0.1 and no more than 0.6.
Exclusion criteria
Exclusion criteria: 1. For the research eye (1) Ocular trauma, Corneal transparency changes affecting vision, ocular tumors, macular hole, retinal vein occlusion, age-related macular degeneration, central serous retinopathy, congenital retinal disease, and any other eye diseases which caused changes of retinal structure or function are excluded; (2) All diseases that can lead to CNV, including AMD, pathologic myopia or Ocular histoplasmosis; (3) Afferent pupillary defect (APD); (4) All kinds of glaucoma or ocular hypertension; (5) History of ocular herpes infections or ocular toxoplasmosis; 2. Eye treatment: a history of intraocular surgery for the research eye; 3. General condition: (1) Stroke, coronary heart disease, history of angina , renal dysfunction requiring dialysis or kidney transplantationand any other chronic diseases that do not suit to participate in clinical trials; (2) Allergic to fluorescein sodium; (3) Proved with uncontrolled high blood pressure defined as systolic blood pressure greater than 160mmHg or diastolic blood pressure greater than 100mmHg in the screening or baseline visit. Patients can begin to accept antihypertensive treatment. But the next eligibility assessment must be taken at least 30 days after treatment; (4) Coagulant function abnormal or in application of anticoagulant drugs (such as aspirin) treatment; (5) Stroke or myocardial infarction occurred within 3 months before the screening visit; (6) Patients have participated in any clinical drug research within a month or five experimental drug half-life times before treatment; (7) In the 3 months prior to enrollment, patients have received focal or grid pattern photocoagulation treatment; (8)In the latest 5 years, patients had a history of cancer in any organ system (except the basal fine carcinoma in local skin). No matter whether to accept treatment, or any evidence of local recurrence or metastasis; (9) The patients may need systemic use of drugs which are known toxic for the lens, retina or optic nerve now or in the near future, including chloroquine/hydroxychloroquine, phenothiazine, ethambutol, deferoxamine, and tamoxifen; (10) Corticosteroids was systemically used for at least 30 days in 6 months prior to screening. 4. Others Pregnant or breast-feeding women. Pregnancy refers to the state of women after conception until the pregnancy terminated, which is confirmed by laboratory tests of human chorionic gonadotropin (HCG).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| best corrected visual acuity;Optical coherent tomography;multifocal electroretinograms;microperimetry;Amsler grid; | — |
Countries
China
Contacts
The First Affiliated Hospital of Third Military Medical University,PLA