Effects of Copaxone in the Retinal Function in Diabetic Patients After Panphotocoagulation
Information source: Federal University of São Paulo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Retinopathy
Intervention: Glatiramer acetate (Copaxone) (Drug); Mannitol (Drug)
Phase: Phase 4
Status: Active, not recruiting
Sponsored by: Federal University of São Paulo Official(s) and/or principal investigator(s): Augusto Paranhos Jr, MD, Principal Investigator, Affiliation: Federal University of Sao Paulo
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.
Clinical Details
Official title: Effects of Glatiramer Acetate (Copaxone) in the Nerve Fiber Layer Thickness and Retinal Function in Diabetic Patients After Pan- Retinal Photocoagulation (PRP), a Double- Masked Randomized Clinical Trial.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Retinal function
Secondary outcome: Nerve fiber layer thickness
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 "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
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Federal University of Sao Paulo, Sao Paulo, SP 04023-900, Brazil
Additional Information
Related publications: Perlman I, Gdal-On M, Miller B, Zonis S. Retinal function of the diabetic retina after argon laser photocoagulation assessed electroretinographically. Br J Ophthalmol. 1985 Apr;69(4):240-6. Stitt AW, Gardiner TA, Archer DB. Retinal and choroidal responses to panretinal photocoagulation: an ultrastructural perspective. Graefes Arch Clin Exp Ophthalmol. 1995 Nov;233(11):699-705.
Starting date: July 2006
Last updated: May 13, 2008
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