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

Primary Purpose

Diabetic Retinopathy

Status

Unknown status

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Glatiramer acetate (Copaxone)

Mannitol

About this trial

This is an interventional treatment trial for Diabetic Retinopathy focused on measuring diabetic retinopathy, panretinal photocoagulation, copaxone, nerve fiber layer thickness, retinal function

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Federal University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Group which received Copaxone

Group which received Mannitol

Outcomes

Primary Outcome Measures

Retinal function

Secondary Outcome Measures

Nerve fiber layer thickness

Full Information

NCT ID

NCT00677664

First Posted

May 12, 2008

Last Updated

May 13, 2008

Sponsor

Federal University of São Paulo

1. Study Identification

Unique Protocol Identification Number

NCT00677664

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Unknown status

Study Start Date

July 2006 (undefined)

Primary Completion Date

July 2008 (Anticipated)

Study Completion Date

September 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Federal University of São Paulo

4. Oversight

Data Monitoring Committee

5. Study Description

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 "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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Retinopathy

Keywords

diabetic retinopathy, panretinal photocoagulation, copaxone, nerve fiber layer thickness, retinal function

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Group which received Copaxone

Arm Title

Arm Type

Placebo Comparator

Arm Description

Group which received Mannitol

Intervention Type

Drug

Intervention Name(s)

Glatiramer acetate (Copaxone)

Other Intervention Name(s)

Copaxone (Glatiramer acetate, COP, Copolymer-1)

Intervention Description

Drug was offered by subcutaneous administration one week prior and in the three sections of PRP, one per week.

Intervention Type

Drug

Intervention Name(s)

Mannitol

Intervention Description

Drug was offered by subcutaneous administration one week prior and in the three sections of PRP, one per week.

Primary Outcome Measure Information:

Title

Retinal function

Time Frame

one year

Secondary Outcome Measure Information:

Title

Nerve fiber layer thickness

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Augusto Paranhos Jr, MD

Organizational Affiliation

Federal University of Sao Paulo

Official's Role

Principal Investigator

Facility Information:

Facility Name

Federal University of Sao Paulo

City

Sao Paulo

State/Province

ZIP/Postal Code

04023-900

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

4039601

Citation

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. doi: 10.1136/bjo.69.4.240.

Results Reference

background

PubMed Identifier

8566826

Citation

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. doi: 10.1007/BF00164672.

Results Reference

background

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

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