Retinal vein occlusion and low-dose fibrinolytic therapy (R.O.L.F.): a prospective, randomized, controlled multicenter study of low-dose recombinant tissue plasminogen activator versus hemodilution in retinal vein occlusion.

Abstract

PURPOSE:

To investigate the efficacy of intravenous thrombolysis with low-dose recombinant tissue plasminogen activator (rt-PA) in recent-onset central retinal vein occlusion (CRVO) or branch retinal vein occlusion.

METHODS:

This was a prospective, randomized, controlled multicenter trial in patients with CRVO or branch retinal vein occlusion, best-corrected visual acuity < or =20/50, and onset of symptoms within 11 days before treatment. In each group, patients were randomized to either hemodilution or thrombolysis with 50 mg of rt-PA with concomitant intravenous heparinization. The primary clinical outcome measure was improvement in best-corrected visual acuity from baseline at 1 year.

RESULTS:

Fifty-two subjects were enrolled in the study. Patients with CRVO (n = 41) who were treated with rt-PA exhibited a significant improvement in best-corrected visual acuity compared with those who received hemodilution (P < 0.0001). At 1-year follow-up, the proportion of eyes with CRVO achieving an improvement in visual acuity of three or more lines was 45% after treatment with rt-PA and 21% after hemodilution therapy. The median final best-corrected visual acuity among CRVO patients given rt-PA was 20/60 (light perception, 20/15) compared with 20/400 (light perception, 20/20) in the hemodilution group. There were no significant differences among patients with branch retinal vein occlusion (n = 11). We observed no serious adverse events. No significant differences were found regarding the development of ocular neovascularization.

CONCLUSION:

Treatment with intravenous low-dose rt-PA improved visual outcome in CRVO. Thrombolysis was not associated with a lower risk of ocular neovascularization, indicating that the mechanisms involved in this process occur at an early stage.

• Authors: Lars-Olof Hattenbach, Carl Friedrich Arndt, Ralf Lerche, Inge Scharrer, Holger Baatz, Fabrice Margaron, Gisbert Richard, Wolfgang Behrens-Baumann, Christian Ohrloff
• Journal: Retina (Philadelphia, Pa.) (Retina) 2009 Jul-Aug Vol. 29 Issue 7 Pg. 932-40 ISSN: 1539-2864 [Electronic] United States
• PMID: 19584651 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Fibrinolytic Agents
• Recombinant Proteins
• Tissue Plasminogen Activator

Topics

• Adult
• Aged
• Dose-Response Relationship, Drug
• Female
• Fibrinolytic Agents (administration & dosage, adverse effects)
• Fluorescein Angiography
• Follow-Up Studies
• Hemodilution (adverse effects)
• Humans
• Injections, Intravenous
• Male
• Middle Aged
• Recombinant Proteins (administration & dosage)
• Retinal Vein Occlusion (diagnosis, physiopathology, therapy)
• Thrombolytic Therapy (adverse effects, methods)
• Tissue Plasminogen Activator (administration & dosage, adverse effects)
• Visual Acuity (drug effects)