Steroid Injections vs. Standard Treatment for Macular Edema Due to Retinal Blood Vessel Blockage
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|ClinicalTrials.gov Identifier: NCT00106132|
Recruitment Status : Completed
First Posted : March 21, 2005
Last Update Posted : March 4, 2008
|First Submitted Date ICMJE||March 19, 2005|
|First Posted Date ICMJE||March 21, 2005|
|Last Update Posted Date||March 4, 2008|
|Study Start Date ICMJE||March 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00106132 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Steroid Injections vs. Standard Treatment for Macular Edema Due to Retinal Blood Vessel Blockage|
|Official Title ICMJE||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:
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:
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.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Phase 3|
|Study Design ICMJE||Primary Purpose: Treatment|
|Intervention ICMJE||Drug: Triamcinolone Acetonide|
|Study Arms ICMJE||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date ICMJE||November 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
General Inclusion Criteria:
Ocular Inclusion Criteria (study eye):
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:
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.
General Exclusion Criteria:
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.
D. Sitting systolic blood pressure greater than 180 mmHg or diastolic blood pressure greater than 110 mmHg at the screening visit. If the initial reading exceeds these values, a second reading may be taken two or more hours later; the patient may be included (if all other inclusion criteria are met) in the study if the second reading demonstrates a systolic blood pressure equal to or less than 180 mmHg and the diastolic blood pressure is 110 mmHg or less. If the blood pressure is brought to 180 mmHg systolic or less and 110 mmHg diastolic or less by antihypertensive treatment, the patient can become eligible.
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.
Ocular Exclusion Criteria (study eye):
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.
I. History of pars plana vitrectomy.
J. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within 6 months prior to randomization or anticipated within the next 6 months following randomization.
K. History of YAG capsulotomy performed within 2 months prior to randomization.
L. IOP greater than or equal to 25 mm Hg.
M. Exam evidence of pseudoexfoliation.
N. History of steroid-induced IOP elevation that required IOP-lowering treatment.
O. History of open angle glaucoma (either primary open angle glaucoma or other cause of open angle glaucoma; note: prior angle closure glaucoma is not an exclusion).
P. History of herpetic ocular infection.
Q. History of ocular toxoplasmosis.
S. Exam evidence of external ocular infection, including conjunctivitis, chalazion or significant blepharitis.
T. History of macular detachment.
U. Exam evidence of any diabetic retinopathy, defined as eyes of diabetic patients with more than one microaneurysm outside the area of the vein occlusion (inclusive of both eyes).
V. History of idiopathic central serous chorioretinopathy.
Fellow (Non-Study) Eye Criteria (the Fellow Eye Must Meet the Following):
A. ETDRS visual acuity score of greater than or equal to 19 letters (approximately 20/400)
B. No prior history of intravitreal corticosteroid injection.
C. IOP less than 25 mm Hg.
D. No exam evidence of pseudoexfoliation.
E. No history of steroid-induced IOP elevation that required IOP lowering treatment.
F. No history of open-angle glaucoma (either primary open-angle glaucoma or other cause of open-angle glaucoma; note: angle-closure glaucoma is not an exclusion).
|Ages ICMJE||Child, Adult, Older Adult|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00106132|
|Other Study ID Numbers ICMJE||050101
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Eye Institute (NEI)|
|Collaborators ICMJE||Not Provided|
|Investigators ICMJE||Not Provided|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||November 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP