Diabetic Retinopathy Clinical Trial
NCT number | NCT00000154 |
Other study ID # | NEI-56 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | September 23, 1999 |
Last updated | June 23, 2005 |
Start date | October 1976 |
Verified date | October 1999 |
Source | National Eye Institute (NEI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
To compare two therapies, early vitrectomy and conventional management, for recent severe
vitreous hemorrhage secondary to diabetic retinopathy. Conventional management includes
vitrectomy if hemorrhage fails to clear during a waiting period of 6 to 12 months or if
retinal detachment involving the center of the macula develops at any time.
To compare early vitrectomy and conventional management in eyes that have good vision but a
poor prognosis because they are threatened with hemorrhage or retinal detachment from very
severe proliferative retinopathy.
To study the natural history of severe proliferative diabetic retinopathy.
Status | Completed |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility | Men and women eligible for the vitreous hemorrhage group had at least one eye with recent severe vitreous hemorrhage (within 5 months) and visual acuity of 5/200 or less. Patients eligible for the "very severe proliferative retinopathy with useful vision" group had extensive active fibrovascular proliferations and visual acuity of 10/200 or better. |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
National Eye Institute (NEI) |
Early vitrectomy for severe proliferative diabetic retinopathy in eyes with useful vision. Clinical application of results of a randomized trial--Diabetic Retinopathy Vitrectomy Study Report 4. The Diabetic Retinopathy Vitrectomy Study Research Group. Ophthalmology. 1988 Oct;95(10):1321-34. — View Citation
Early vitrectomy for severe proliferative diabetic retinopathy in eyes with useful vision. Results of a randomized trial--Diabetic Retinopathy Vitrectomy Study Report 3. The Diabetic Retinopathy Vitrectomy Study Research Group. Ophthalmology. 1988 Oct;95(10):1307-20. — View Citation
Early vitrectomy for severe vitreous hemorrhage in diabetic retinopathy. Four-year results of a randomized trial: Diabetic Retinopathy Vitrectomy Study Report 5. Arch Ophthalmol. 1990 Jul;108(7):958-64. Erratum in: Arch Ophthalmol 1990 Oct;108(10):1452. — View Citation
Early vitrectomy for severe vitreous hemorrhage in diabetic retinopathy. Two-year results of a randomized trial. Diabetic Retinopathy Vitrectomy Study report 2. The Diabetic Retinopathy Vitrectomy Study Research Group. Arch Ophthalmol. 1985 Nov;103(11):1644-52. — View Citation
Two-year course of visual acuity in severe proliferative diabetic retinopathy with conventional management. Diabetic Retinopathy Vitrectomy Study (DRVS) report #1. Ophthalmology. 1985 Apr;92(4):492-502. — View Citation
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