Laser and Medical Treatment of Diabetic Macular Edema

NCT00027287 | Completed Phase 1

• 2 other identifiers: 02006302-EI-0063
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the side effects of two laser treatments for diabetic macular edema, a common condition in patients with diabetes. In macular edema, blood vessels in the retina-a thin layer of tissue that lines the back of the eye-become leaky and the retina swells. The macula-the center part of the retina that is responsible for fine vision-may also swell and cause vision loss. Traditional laser treatment (argon blue or green or yellow) for macular swelling, or edema, causes scarring that can expand and possibly lead to more loss of vision. Studies with a different type of laser (diode) have shown no adverse effects to the retina, but long-term effects of this treatment are not known. The results of this study on side effects of the treatments will be used to design a larger study of effectiveness. This study will also examine whether vitamin E can reduce the damage caused by laser treatment. Patients with diabetic eye disease who take vitamin E have increased blood flow through the vessels of the retina, as well as improved kidney function. Patients with elevated cholesterol levels will be invited to participate in a cholesterol reduction part of the study to compare normal-pace cholesterol reduction with accelerated reduction. Patients 18 years of age and older with type 1 or type 2 diabetes and macular edema may be eligible for this study. Candidates will be screened with the following tests and procedures:

• Medical history - to review past medical conditions and treatments.
• Physical examination - to measure vital signs (pulse, blood pressure, temperature, breathing rate) and examine the head and neck, heart, lungs, abdomen, arms and legs.
• Eye examination - to assess visual acuity (eye chart test) and examine pupils, lens, retina, and eye movements. The pupils will be dilated with drops for this examination.
• Blood tests - to measure cholesterol and vitamin E blood levels, blood clotting time, hemoglobin A1C (a measure of diabetes control), and to evaluate liver and kidney function.
• Photography - to help evaluate the status of the retina and changes that may occur in the future. Special photographs of the inside of the eye are taken using a camera that flashes a bright light into the eye. From 2 to 20 pictures may be taken, depending on the eye condition.
• Fluorescein angiography - to evaluate the eye's blood vessels. A yellow dye is injected into an arm vein and travels to the blood vessels in the eyes. Pictures of the retina are taken using a camera that flashes a blue light into the eye. The pictures show if any dye has leaked from the vessels into the retina, indicating possible blood vessel abnormality. Participants will be randomly assigned to receive one of the two laser treatments. They will also be randomly assigned to take 1600 IU of vitamin E or placebo (an inactive, look-alike pill) daily. For the laser treatment, eye drops are put in the eye to numb the surface and a contact lens is placed on the eye during the laser beam application. Several visits may be required for additional laser treatments. The maximum number of treatments depends on how well the treatment is working. On their first visit, patients will be given vitamin C. After taking the vitamin for 1 month, they will return to the clinic for the first laser treatment. They will followed 1, 3, 6, 9, and 12 months after the first treatment, and then every 6 months until either 1) the patient returns for a 3-year visit; 2) the last enrolled patient returns for the 1-year visit, or the patient requests to leave the study. During these visits, several of the exams described above will be repeated to evaluate the response to treatment and check for side effects of the vitamin E.

Conditions

Diabetes Mellitus; Macular Edema

Keywords

Type I Diabetes; Type 2 Diabetes; Diode Laser Photocoagulation; Vitamin E; Elevated Low-Density Lipoprotein (LDL-C) Cholesterol; Diabetic Retinopathy; Macular Edema; Type II Diabetes

Interventions

Vitamin E DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with type 1 or 2 diabetes.
• Patients with clinically significant macular edema in at least one eye.
• Best corrected visual acuity 20/400 or better as measured on an ETDRS chart in the eye with clinically significant macular edema; this eye will be considered the study eye. If both eyes have clinically significant macular edema and best corrected visual acuity greater than or equal to 20/400, the right eye will be considered the study eye.
• May have had proliferative diabetic retinopathy but scatter photocoagulation must be performed more than six months ago.
• Ocular media sufficiently clear to allow for quality fundus photography.
• If Aphakic or pseudophakic, lens removal must have occurred at least 6 months prior to enrollment.
• Clinical diagnosis of diabetes based on any one of the criteria (determined by medical physician):
• Documented history of plasma glucose value greater than 210 mg/dl on 3 different occasions.
• Fasting blood sugar greater than 150 mg/dl on 3 different occasions.
• Documented history of ketoacidosis.
• Insulin dependency.
• Documented history of abnormal glucose tolerance test.
• Patient's medical status must include a likelihood of survival for 5
• years.
• Hemoglobin A1C 12 percent or less.

You may not qualify if:

• Retinopathy that requires scatter photocoagulation immediately.
• Ocular disease other than diabetic retinopathy that may confound the outcome of the study (e.g. age-related macular degeneration, drug toxicity, uveitis, etc.).
• Had previous focal laser photocoagulation for diabetic macular edema.
• Poor survival due to other systemic diseases (separate from diabetes)
• Poor glycemic control with hemoglobin A1C greater than 12 percent.
• Past or current liver disease, which precludes the use of the lipid-lowering drugs.
• Vitamin E supplementation over and above the amount in a multivitamin (30 IU/day) one month prior to entry into the study.
• History of hypersensitivity to fluorescein.
• History of intra-cranial bleeds.
• Evidence of other ocular diseases that may confound the assessment of treatment of diabetic macular edema.
• Prior or current macular detachment in the affected eye(s).
• Concurrent celebrex or any other COX-2 inhibitor within 7 days prior to baseline.
• Concurrent coumadin therapy or known bleeding diathesis.
• Concurrent treatment with a new investigational drug.
• Concurrent lithium therapy

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Eye Institute (NEI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Photocoagulation for diabetic macular edema. Early Treatment Diabetic Retinopathy Study report number 1. Early Treatment Diabetic Retinopathy Study research group. Arch Ophthalmol. 1985 Dec;103(12):1796-806.

  PMID: 2866759 BACKGROUND

• The effect of intensive diabetes treatment on the progression of diabetic retinopathy in insulin-dependent diabetes mellitus. The Diabetes Control and Complications Trial. Arch Ophthalmol. 1995 Jan;113(1):36-51. doi: 10.1001/archopht.1995.01100010038019.

  PMID: 7826293 BACKGROUND

• Grattagliano I, Vendemiale G, Boscia F, Micelli-Ferrari T, Cardia L, Altomare E. Oxidative retinal products and ocular damages in diabetic patients. Free Radic Biol Med. 1998 Aug;25(3):369-72. doi: 10.1016/s0891-5849(98)00059-8.

  PMID: 9680184 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Macular Edema; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetic Retinopathy

Interventions

Vitamin E

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications

Intervention Hierarchy (Ancestors)

Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 29, 2001
• First Posted: November 30, 2001
• Study Start: November 1, 2001
• Study Completion: December 1, 2002
• Last Updated: March 4, 2008

Record last verified: 2002-12

Locations

US (1)