Adjunctive daunorubicin in the treatment of proliferative vitreoretinopathy: results of a multicenter clinical trial. Daunomycin Study Group.

Abstract

PURPOSE:

To assess the efficacy and safety of adjunctive daunorubicin during vitrectomy surgery in eyes with idiopathic proliferative vitreoretinopathy (PVR).

METHODS:

Two hundred eighty-six eyes (286 patients) with stage C2 (Retina Society Classification, 1983) or more advanced preoperative PVR in which surgery with silicone oil was planned were enrolled in a multicenter, prospective, randomized, controlled clinical trial. Standardized surgery plus adjunctive daunorubicin perfusion was compared with surgery alone. Outcomes assessed were retinal attachment without additional vitreoretinal surgery 6 months after standardized surgery, number of and time until vitreoretinal reoperations within 1 year of standardized surgery, and change in visual acuity 1 year after standardized surgery, evaluated by photodocumentation, number of reoperations, and measurement of best-corrected visual function. Outcomes were determined 6 months after operation and reevaluated after 1 year of follow-up.

RESULTS:

Six months after standardized surgery, complete retinal reattachment without additional vitreoretinal surgery was achieved in 62.7% (89/142) of eyes in the daunorubicin group vs 54.1% (73/135) in the control group (P = .07, one-sided). However, in the daunorubicin group, significantly fewer vitreoretinal reoperations were performed within 1 year postoperatively (P = .005, one-sided) to achieve the same overall 1-year retinal reattachment rate (80.2% [105/131] vs 81.8% [103/126]). The rate of patients with no vitreoretinal reoperations was 65.5% (95/145) in the daunorubicin group vs 53.9% (76/141) in the control group. There was no difference in the best-corrected visual acuity. No severe adverse effect related to daunorubicin was identified.

CONCLUSIONS:

Although the rate of anatomic success after 6 months failed to show significance, some benefit of the adjunctive treatment exists, especially a tendency toward increased rate of reattachment and a significant reduction in the number of reoperations. This shows that human PVR is amenable to pharmacologic treatment.

• Authors: P Wiedemann, R D Hilgers, P Bauer, K Heimann
• Journal: American journal of ophthalmology (Am J Ophthalmol) Vol. 126 Issue 4 Pg. 550-9 (Oct 1998) ISSN: 0002-9394 [Print] United States
• PMID: 9780100 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibiotics, Antineoplastic
• Daunorubicin

Topics

• Adult
• Aged
• Antibiotics, Antineoplastic (therapeutic use)
• Chemotherapy, Adjuvant
• Daunorubicin (therapeutic use)
• Female
• Follow-Up Studies
• Humans
• Male
• Middle Aged
• Prospective Studies
• Safety
• Scleral Buckling
• Treatment Outcome
• Visual Acuity
• Vitrectomy
• Vitreoretinopathy, Proliferative (drug therapy, pathology, surgery)