effects of copaxone in the retinal function in diabetic patients after panphotocoagulation

Conditions: Diabetic Retinopathy

Summary: the purpose of this study is to evaluate the effects of copaxone injections in retinal function and integrity in diabetic patients who underwent pan-retinal photocoagulation.

purpose: to evaluate the neuroprotective effect of copaxone (glatiramer acetate) injections in the nerve fiber layer thickness and retinal function in diabetic patients who underwent panretinal photocoagulation (prp). study design: double- masked randomized clinical trial. the follow up period estimated is 12 months after the last prp section. patients enrollment: thirty patients with severe nonproliferative or early proliferative diabetic retinopathy and no previous laser treatment were enrolled. they were divided into two groups: "a" which received copaxone or "b"which received mannitol (placebo) using a block randomization. both drugs were offered by subcutaneous administration one week prior and in the three sections of prp, one per week. all patients received and signed a written inform consent approved by the research ethics committee of unifesp. chronogram: all patients received a full ophthalmic examination (best-corrected log-mar visual acuity, slit lamp examination, applanation tonometry, fundus biomicroscopy and indirect fundus examination); functional examination (humphrey 24-2 sita standard visual field, electroretingrams and fdt c-20 strategy visual field) and anatomic examination (color digital photography and fluorescein angiography (fag), gdx- vcc, optical coherence tomography (oct) and heidelberg retinal tomography (hrt) before prp and 1st,3rd,6th months and 1 year after laser, or whenever needed for clinical reasons.

Eligibility criteria:
inclusion criteria: * sex: males or females; females must be post-menopausal for 6 months and must have a negative pregnancy test (serum β-hcg) prior to study entry * age: 18 to 70 years old * type 1 or 2 diabetes, assigned for pan-retinal photocoagulation * vision acuity 20/100 or better * se of ±6,00 de * volunteer must be willing and able to sign an informed consent * volunteer must be ambulatory and not requiring skilled nursing care * normal skin appearance in areas to be injected (no tattoo, scars, birth marks etc.) exclusion criteria: * eye related: * dense cataract or vitreous opacity * other retinal disease but diabetic retinopathy * glaucoma (iop higher than 21 mmhg and or cup disk ratio equal higher than 0.8) or other optic nerve diseases * other eye threatening systemic diseases * no ocular surgery in the last 6 months including laser treatment * no previous retinal photocoagulation or cryopexy of any kind * systemic exclusion criteria: * known immunological condition/disease * no active infection within 30 days prior to enrollment (e.g. urinary tract infection, upper/lower respiratory tract infection, skin infection, arthritis etc.) * use of interferons, immunosuppressive therapy, cytotoxic, corticosteroids, chemotherapy or lymphoid irradiation within 1 year prior to study entry. * serious disease in the past or an unstable disease such as cancer, pulmonary, hepatic, renal, cardiovascular or metabolic diseases * history of alcoholism or drug addiction within the past year * volunteer has participated in another clinical trial within the past 90 days or took an experimental drug within time scale of 5 x t1/2 of the experimental drug * unstable psychiatric illness

Keywords: diabetic retinopathy panretinal photocoagulation copaxone nerve fiber layer thickness retinal function