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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

Page last updated: August 23, 2015

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