Titre du document / Document title

Comparison of Recombinant transforming growth factor-beta-2 and placebo as an adjunctive agent for macular hole surgery

Auteur(s) / Author(s)

THOMPSON J. T. ; SMIDDY W. E. ⁽¹⁾ ; WILLIAMS G. A. ⁽²⁾ ; SJAARDA R. N. ; FLYNN H. W. ⁽¹⁾ ; MARGHERIO R. R. ⁽²⁾ ; ABRAMS G. W. ⁽³⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ The Bascom Palmer Eye Institute, Miami, Florida, ETATS-UNIS
⁽²⁾ Associated Retinal Consultants, Royal Oak, Michigan, ETATS-UNIS
⁽³⁾ Kresge Eye Institute, Detroit, Michigan, ETATS-UNIS

Résumé / Abstract

Objective: This study aimed to compare the visual and anatomic results of macular hole surgery in eyes treated with recombinant transforming growth factor-beta-2 (TGF-β₂) or placebo. Design: The design was a prospective, multicenter, randomized, double-masked, placebo-controlled clinical study. Participants: One hundred thirty eyes with idiopathic macular holes of 1 year or less and a refracted Early Treatment Diabetic Retinopathy Study visual acuity of 20/80 or worse were treated with 1.1 μg recombinant TGF-β₂or placebo to the macular hole after fluid-gas exchange. Intervention: The effect of recombinant TGF-β₂ as an adjunctive agent for macular hole surgery was evaluated. Main Outcome Measures: Closure of the macular hole and change in visual acuity at 3 months were measured. Results: The 3-month visits were completed for 120 eyes. The macular hole was closed at 3 months in 35 (61.4%) of 57 eyes treated with placebo and 49 (77.8%) of 63 eyes treated with recombinant TGF-β₂ (P = 0.08). The mean visual acuity gain was +6.4 letters in eyes receiving placebo and +8.9 letters in eyes treated with recombinant TGF-β₂ (P = 0.27). Visual acuity improved 2 or more lines in 23 (40.4%) of 57 eyes treated with placebo and 30 (47.6%) of 63 eyes treated with recombinant TGF-β₂ (P = 0.42). Intraocular pressure elevation greater than 30 mmHg was more common 2 weeks after surgery in eyes treated with recombinant TGF-β₂ (P < 0.001). Conclusions: Recombinant TGF-fl₂resulted in a similar proportion of successful closure of macular holes as placebo. There was no statistically significant visual acuity benefit with the use of recombinant TGF-β₂ for the treatment of macular holes.

Revue / Journal Title

Ophthalmology   ISSN 0161-6420   CODEN OPHTDG 

Source / Source

Congrès
Annual Meeting of the American Academy of Ophthalmology (30/10/1995)
1998, vol. 105, n^o4, pp. 700-706 (22 ref.)

Langue / Language

Anglais

Editeur / Publisher

Elsevier, New York, NY, ETATS-UNIS  (1976) (Revue)

Mots-clés anglais / English Keywords

Macular hole ; Surgery ; Adjuvant treatment ; Transforming growth factor β ; Chemotherapy ; Placebo ; Comparative study ; Recombinant protein ; Human ; Eye disease ; Retinopathy ; Maculopathy ;

Mots-clés français / French Keywords

Trou maculaire ; Chirurgie ; Traitement adjuvant ; Facteur croissance transformant β ; Chimiothérapie ; Placebo ; Etude comparative ; Protéine recombinante ; Homme ; Oeil pathologie ; Rétinopathie ; Maculopathie ;

Mots-clés espagnols / Spanish Keywords

Agujero macular ; Cirugía ; Tratamiento adyuvante ; Factor crecimiento transformante β ; Quimioterapia ; Placebo ; Estudio comparativo ; Proteína recombinante ; Hombre ; Ojo patología ; Retinopatía ; Maculopatía ;

Localisation / Location

INIST-CNRS, Cote INIST : 18914, 35400007518021.0230