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Effects of Copaxone in the Retinal Function in Diabetic Patients After Panphotocoagulation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Federal University of São Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00677664
First received: May 12, 2008
Last updated: May 13, 2008
Last verified: May 2008
History of Changes
  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 4

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:

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:

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 May 19, 2013