Diabetic Retinopathy
Conditions
Keywords
diabetic retinopathy, panretinal photocoagulation, copaxone, nerve fiber layer thickness, retinal function
Brief 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.
Detailed description
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 Bwhich 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.
Interventions
DRUGGlatiramer acetate (Copaxone)
Drug was offered by subcutaneous administration one week prior and in the three sections of PRP, one per week.
DRUGMannitol
Drug was offered by subcutaneous administration one week prior and in the three sections of PRP, one per week.
Sponsors
Federal University of São Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Retinal function | one year |
Secondary
| Measure | Time frame |
|---|---|
| Nerve fiber layer thickness | one year |
Countries
Brazil
Outcome results
None listed