Effects of Copaxone in the Retinal Function in Diabetic Patients After Panphotocoagulation - Full Text View

Sponsor:	Federal University of São Paulo
Information provided by:	Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT00677664

Purpose

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.

Condition	Intervention	Phase
Diabetic Retinopathy	Drug: Glatiramer acetate (Copaxone) Drug: Mannitol	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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.

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetic Eye Problems Dietary Fiber Retinal Disorders

Drug Information available for: Mannitol Copolymer 1

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:

Retinal function [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Nerve fiber layer thickness [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment:	30
Study Start Date:	July 2006
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A Group which received Copaxone	Drug: Glatiramer acetate (Copaxone) Drug was offered by subcutaneous administration one week prior and in the three sections of PRP, one per week. Other Name: Copaxone (Glatiramer acetate, COP, Copolymer-1)
Placebo Comparator: B Group which received Mannitol	Drug: Mannitol Drug was offered by subcutaneous administration one week prior and in the three sections of PRP, one per week.

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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00677664

Locations

Brazil
Federal University of Sao Paulo
Sao Paulo, SP, Brazil, 04023-900

Sponsors and Collaborators

Federal University of São Paulo

Investigators

Principal Investigator:

Augusto Paranhos Jr, MD

Federal University of Sao Paulo

More Information

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.

Responsible Party:	Augusto Paranhos Jr, PHD, Federal University of Sao Paulo
ClinicalTrials.gov Identifier:	NCT00677664 History of Changes
Other Study ID Numbers:	COP 001
Study First Received:	May 12, 2008
Last Updated:	May 13, 2008
Health Authority:	Brazil: National Committee of Ethics in Research; Brazil: Ministry of Health; Brazil: National Health Surveillance Agency

Keywords provided by Federal University of São Paulo:

diabetic retinopathy
panretinal photocoagulation
copaxone
nerve fiber layer thickness
retinal function

Additional relevant MeSH terms:

Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Mannitol
Copolymer 1

Diuretics, Osmotic
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Adjuvants, Immunologic
Immunologic Factors
Immunosuppressive Agents

ClinicalTrials.gov processed this record on February 09, 2012