Macular Edema Clinical Trial
Official title:
The Standard Care vs. Corticosteroid for Retinal Vein Occlusion (SCORE) Study
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.
Macular edema is a major cause of vision loss in patients with central retinal vein
occlusion (CRVO) and branch retinal vein occlusion (BRVO). Currently, there is no effective
treatment for macular edema associated with CRVO. For macular edema associated with BRVO,
grid laser photocoagulation may be an effective treatment, but many patients derive limited
benefit from this treatment. Therefore, the development of new treatment modalities to treat
macular edema caused by these two conditions is an important research goal. The Standard
Care vs. COrticosteroid for REtinal Vein Occlusion (SCORE) Study will compare the efficacy
and safety of standard care with intravitreal injection(s) of triamcinolone acetonide to
treat macular edema associated with CRVO and BRVO.
The SCORE Study is designed as a multicenter, randomized, Phase III trial to compare the
efficacy and safety of standard care versus triamcinolone acetonide injection(s) for the
treatment of macular edema associated with CRVO and BRVO. In each of the two disease areas,
630 participants will be randomized in a 1:1:1 ratio to one of three groups: standard care,
intravitreal triamcinolone 4 mg, or intravitreal triamcinolone 1 mg. For CRVO participants,
standard care consists of observation of the macular edema. For BRVO participants, standard
care consists of immediate grid laser photocoagulation for study eyes without a dense
macular hemorrhage. For study eyes of BRVO participants with a dense macular hemorrhage,
standard care is observation followed by grid laser photocoagulation if and when clearing of
the hemorrhage permits grid laser photocoagulation. For all three groups, neovascular
complications will be treated as necessary. Repeat treatments will be provided as clinically
indicated based on protocol-specific guidelines. Participants will be followed for 3 years
after randomization. The primary efficacy outcome of this study is improvement by 15 or more
letters from baseline in best-corrected ETDRS visual acuity score at the 12-month visit.
Secondary efficacy outcomes include change between baseline and each efficacy outcome
assessment visit in best-corrected ETDRS visual acuity score, change in retinal thickness at
the center of the macula and change in area of retinal thickening as assessed by
stereoscopic color fundus photography, and change in retinal thickness and calculated
retinal thickening as assessed by optical coherence tomography. Safety outcomes include
injection-related adverse events such as infectious endophthalmitis, non-infectious
endophthalmitis, retinal detachment, and vitreous hemorrhage and steroid-related adverse
events, which include cataract and elevated intraocular pressure.
;
Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
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