Diabetic Retinopathy Vitrectomy Study (DRVS)

NCT00000154 | Completed Phase 3

• 1 other identifier: NEI-56
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Diabetic Retinopathy; Retinal Detachment; Vitreous Hemorrhage

Interventions

Vitrectomy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Related Publications (5)

• 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. doi: 10.1016/s0161-6420(85)34002-2.

  PMID: 4000644 BACKGROUND

• 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.

  PMID: 2865943 BACKGROUND

• 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. doi: 10.1016/s0161-6420(88)33015-0.

  PMID: 2465517 BACKGROUND

• 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. doi: 10.1016/s0161-6420(88)33014-9.

  PMID: 2465518 BACKGROUND

• 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. doi: 10.1001/archopht.1990.01070090060040.

  PMID: 2196036 BACKGROUND

MeSH Terms

Conditions

Diabetic Retinopathy; Retinal Detachment; Vitreous Hemorrhage

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Eye Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

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

Study Record Dates

• First Submitted: September 23, 1999
• First Posted: September 24, 1999
• Study Start: October 1, 1976
• Last Updated: June 24, 2005

Record last verified: 1999-10