Steroid Injections vs. Standard Treatment for Macular Edema Due to Retinal Blood Vessel Blockage

NCT00106132 | Completed Phase 3

• 2 other identifiers: 05010105-EI-0101
• Study Type: interventional
• Target: 1,260
• Locations: 1 country
• Sites: 1

Brief Summary

This study will compare the safety and effectiveness of two treatments-injections of triamcinolone acetonide into the eye vs. standard laser therapy-for macular edema (swelling in the center of the retina) that is caused by blockage in a retinal blood vessel. Edema caused by blockage in a large vessel is called central retinal vein occlusion (CRVO). Edema caused by blockage in a smaller vein is called branch retinal vein occlusion (BRVO). Triamcinolone acetonide is a steroid drug that reduces swelling; the Food and Drug Administration has approved it for injection into joints and muscles to treat inflammatory conditions. Patients 18 years of age and older with macular edema due to CRVO or BRVO of between 3 and 18 months' duration may be eligible for this study. Candidates are screened with a medical history, blood pressure measurement, and urine pregnancy test for women who can become pregnant. Screening also includes the following procedures:

• Eye examination to assess visual acuity and eye pressure, and to examine the cornea, lens, and retina. The pupils are dilated with drops for this examination.
• 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.
• Optical coherence tomography to measure retinal thickness. The eye is examined with a machine that produces cross-sectional pictures of the retina. The patient is seated in front of a machine and looks at a pattern of flashing and rotating red and green lights, first with one eye and then with the other.
• Fundus photography to help evaluate the status of the retina and changes that may occur in the future. Photographs of the retina are taken using a camera that flashes a bright light into the eye. Participants are randomly assigned to receive triamcinolone injections or standard treatment. Triamcinolone is given in either a 1-mg or 4-mg dose. Standard treatment for CRVO and for BRVO with excessive blood in the retina is observation. Standard treatment for BRVO without excessive blood is laser therapy. Patients with BRVO who do not qualify for laser therapy when they enter the study may have it later if blood clears enough to permit treatment. The procedures for triamcinolone injections and laser therapy are as follows:
• Triamcinolone acetonide: The eye is numbed with anesthetic drops and the study drug is injected into the vitreous, the jelly-like substance located between the back of the lens and the retina. Patients apply antibiotic drops at home for 3 days following the procedure.
• Laser treatment: The eye is numbed with anesthetic drops and a special contact lens is placed on the eye during the laser beam application. All patients are followed every 4 months for 3 years. Additional visits may be scheduled if needed. Patients who receive triamcinolone injections are also examined within 1 week of each injection and 1 month after each injection. At the 4-month visits patients undergo repeat eye examination and fundus photography. Optical coherence tomography is done at some visits, and fluorescein angiography is repeated at months 4, 12 and 24. Blood pressure is measured at months 12, 24 and 36. Patients may be retreated with triamcinolone injections or laser therapy as often as every 4 months, depending on their response to treatment.

Conditions

Retinal Vein Occlusion; Macular Edema, Cystoid; Macular Edema

Keywords

Macular Edema; Steroid; Fluorescein Angiogram; Ocular Coherence Tomography; Laser; Retinal Vein Occlusion

Interventions

Triamcinolone Acetonide DRUG

Eligibility Criteria

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

You may qualify if:

• Ability and willingness to provide informed consent.
• Sex: Participants may be male or female.
• Age: 18 years or older
• A. Participants must have center-involved macular edema secondary to either CRVO or BRVO. Eyes may be enrolled if macular edema has been documented for at least 3 months and not longer than 18 months (by patient history or ophthalmologic diagnosis). The following definitions are used for the purposes of the SCORE Study:
• A CRVO is defined as an eye that has retinal hemorrhage or other biomicroscopic evidence of retinal vein occlusion (e.g. telangiectatic capillary bed) and a dilated venous system (or previously dilated venous system) in all 4 quadrants.
• A BRVO is defined as an eye that has retinal hemorrhage or other biomicroscopic evidence of retinal vein occlusion (e.g. telangiectatic capillary bed) and a dilated venous system (or previously dilated venous system) in 1 quadrant or less of retina drained by the affected vein.
• A hemiretinal vein occlusion (HRVO) is defined as an eye that has retinal hemorrhage or other biomicroscopic evidence of retinal vein occlusion (e.g. telangiectatic capillary bed) and a dilated venous system (or previously dilated venous system) in more than 1 quadrant but less than all 4 quadrants. Typically, a HRVO is a retinal vein occlusion that involves 2 altitudinal quadrants. For the purposes of the SCORE Study, eyes with HRVO will be treated as eyes with BRVO and analyzed with the BRVO group.
• B. ETDRS visual acuity score of greater than or equal to 34 letters (approximately 20/200) and less than or equal to 73 letters (approximately 20/40) by the ETDRS visual acuity protocol at the screening visit.
• C. Mean retinal thickness on two OCT measurements greater than or equal to 250 microns (central subfield) at the screening visit.
• D. Media clarity, pupillary dilation and participant cooperation sufficient for adequate fundus photographs.
• E. Stable visual acuity. This is defined as a less than 10 letter improvement in best-corrected ETDRS visual acuity score between the screening visit and the randomization visit. Those patients with a 10 or more letter improvement between the screening and randomization visits will be declared temporarily ineligible.

You may not qualify if:

• Participants with any of the following conditions are ineligible:
• A. A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., chronic alcoholism or drug abuse, personality disorder or use of major tranquilizers indicating difficulty in long term follow-up, likelihood of survival of less than 3 years).
• B. Participation in an investigational trial within 30 days of study entry that involved treatment with any drug that has not received regulatory approval at time of study entry.
• C. History of allergy to any corticosteroid or component of the delivery vehicle.
• E. The participant will be moving out of the area of the clinical center to an area not covered by another clinical center during the 3 years of the study.
• F. History of systemic (e.g., oral, IV, IM, epidural, bursal) corticosteroids within 4 months prior to randomization or topical, rectal or inhaled corticosteroids in current use more than 2 times per week.
• G. Positive urine pregnancy test: all women of childbearing potential (those who are pre-menopausal and not surgically sterilized) may participate only if they have a negative urine pregnancy test (at either the screening visit or randomization visit), if they do not intend to become pregnant during the timeframe of the study and if they agree to use at least one of the following birth control methods: hormonal therapy such as oral, implantable or injectable chemical contraceptives; mechanical therapy such as spermicide in conjunction with a barrier such as a condom or diaphragm; intrauterine device (IUD); or surgical sterilization of partner.
• A. Exam evidence of vitreoretinal interface disease (e.g. vitreomacular traction, epiretinal membrane), either on clinical examination or optical coherence tomography thought to be contributing to macular edema.
• B. An eye that, in the investigator's opinion, would not benefit from resolution of macular edema such as eyes with foveal atrophy, dense pigmentary changes or dense subfoveal hard exudates.
• C. Presence of an ocular condition that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., age-related macular degeneration, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, prior macula-off rhegmatogenous retinal detachment).
• D. Presence of a substantial cataract that, in the opinion of the investigator, is likely to be decreasing visual acuity by 3 lines or more (i.e. a 20/40 cataract).
• E. History of grid laser photocoagulation for macular edema.
• F. History of intravitreal corticosteroid injection.
• G. History of peribulbar or retrobulbar corticosteroid use for any reason within 6 months prior to randomization.
• H. History of panretinal scatter photocoagulation (PRP) or sector laser photocoagulation within four months prior to randomization or anticipated within the next four months following randomization.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Eye Institute (NEI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Patz A. Argon laser photocoagulation for macular edema in branch vein occlusion. Am J Ophthalmol. 1984 Sep 15;98(3):374-5. doi: 10.1016/0002-9394(84)90331-3. No abstract available.

  PMID: 6540993 BACKGROUND

• Opremcak EM, Bruce RA. Surgical decompression of branch retinal vein occlusion via arteriovenous crossing sheathotomy: a prospective review of 15 cases. Retina. 1999;19(1):1-5. doi: 10.1097/00006982-199901000-00001.

  PMID: 10048366 BACKGROUND

• Baseline and early natural history report. The Central Vein Occlusion Study. Arch Ophthalmol. 1993 Aug;111(8):1087-95. doi: 10.1001/archopht.1993.01090080083022.

  PMID: 7688950 BACKGROUND

MeSH Terms

Conditions

Retinal Vein Occlusion; Macular Edema

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Macular Degeneration; Retinal Degeneration

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 19, 2005
• First Posted: March 21, 2005
• Study Start: March 1, 2005
• Study Completion: November 1, 2005
• Last Updated: March 4, 2008

Record last verified: 2005-11

Locations

US (1)