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Clinicopathologic Reports, Case Reports, and Small Case Series
December 2001

0.01% Becaplermin Gel for the Treatment of a Chronic Orbital Ulcer After Exenteration

Arch Ophthalmol. 2001;119(12):1858-1859. doi:

Chronic orbital epithelial defect is a rare complication that occurs after exenteration. Skin grafts, rotation flaps, or free flaps are the traditional surgical means to correct such abnormalities. We describe a case of a chronic orbital epithelial defect after exenteration refractory to conventional treatment that resolved after being treated with 0.01% topical becaplermin gel (recombinant human platelet–derived growth factor BB [rh-PDGF-BB] or Regranex [Ortho-McNeil Pharmaceuticals Inc, Raritan, NJ]).

Report of a Case

A 57-year-old African American patient with a history of hypertension, seizures, and diabetes underwent a subtotal exenteration with placement of a full-thickness skin graft for primary orbital melanoma. The orbital defect healed slowly for several weeks. A year later the patient underwent placement of craniofacial orbital implants for retention of an orbital prosthesis. Following this procedure, she developed an ulcer at the apex of the socket that measured 15 × 4 mm with elevated edges and what appeared to be granulation tissue at the base of the ulcer (Figure 1). A biopsy specimen of the area demonstrated chronic inflammatory changes. The ulcer was treated with hydrogen peroxide soaks, wet-to-dry dressings twice a day, and discontinued use of the prosthesis (as allowed). The prosthesis was refitted to minimize the pressure at the orbital apex. A course of topical antibiotic cream was also applied. The ulcer, however, did not resolve for 15 months. Discharge was not present and cultures were not obtained. Treatment was then initiated with 0.01% topical becaplermin gel daily, which was the only modification in the treatment regimen. The ulcer gradually decreased in size and was completely healed after 3 weeks (Figure 2). Use of the gel was discontinued a week later without a tapering dose. No recurrence had occurred with a follow-up period of 12 months.

Figure 1.
The socket of the left eye before
treatment with becaplermin. A 15 × 4-mm ulcer is present at the apex
of the orbit. The 2 metal/ implants that hold the orbital prosthesis are seen
at the roof of the orbit.

The socket of the left eye before treatment with becaplermin. A 15 × 4-mm ulcer is present at the apex of the orbit. The 2 metal/ implants that hold the orbital prosthesis are seen at the roof of the orbit.

Figure 2.
The same area 3 weeks after treatment
with becaplermin.

The same area 3 weeks after treatment with becaplermin.


Chronic epithelial defects after exenteration have been described after radiation to the orbit,1 after socket infection, and with diabetes (as occurred in our patient). Skin grafts in these conditions have a high chance of failure because of compromised blood supply. A temporalis rotation muscle flap offers a good chance of cure but requires additional surgery and may deform the temporalis fossa region. Free flaps result in scarring and deformity of the donor site and neck area, where the microvascular anastomosis is performed. Local treatment with agents that promote wound healing is therefore the most simple and cost-effective treatment when taking into account the cost of surgery.

Recombinant human platelet–derived growth factor BB is involved in regulation of all phases of normal wound healing. It is either synthesized or released from all cell types involved in the healing process.2,3 Both rh-PDGF-BB and other growth factor levels have been found to be reduced in chronic, nonhealing wounds.2 Exogenous administration of rh-PDGF-BB in the form of 0.01% becaplermin gel promotes wound healing and was found to be effective for the treatment of diabetic foot ulcer and pressure ulcers in multicenter, double-blind, placebo-controlled trials.4 It is currently the only growth factor approved by the Food and Drug Administration for the treatment of chronic diabetic foot ulcers.

This is the first reported case, to our knowledge, of clinical use of 0.01% becaplermin gel (Regranex) in the ophthalmic literature and suggests that this may be a powerful tool in the treatment of chronic epithelial defects in oculoplastic surgery. The Food and Drug Administration, however, has not yet approved becaplermin for treatment of conditions other than diabetic foot ulcers. Appropriate caution must be exercised by physicians who choose to use this medication.

The authors have no commercial, proprietary, or financial interest in the product mentioned in the article.

Corresponding author: James W. Karesh, MD, Department of Ophthalmology, Krieger Eye Institute, Sinai Hospital of Baltimore, 2411 W Belvedere Ave, Baltimore, MD 21215 (e-mail: jkaresh@lifebridgehealth.org).

Savar  DE High-dose radiation to the orbit: a cause of skin graft failure after exenteration. Arch Ophthalmol. 1982;1001755- 1757Article
Bennett  NTSchultz  GS Growth factors and wound healing: part II: role in normal and chronic wound healing. Am J Surg. 1993;16674- 81Article
Kiritsy  CPLynch  ABLynch  SE Role of growth factors in cutaneous wound healing: a review. Crit Rev Oral Biol Med. 1993;4729- 760
Wieman  TJSmeil  JMSu  Y Efficacy and safety of a topical gel formulation of recombinant human platelet–derived growth factor BB (becaplermin) in patients with chronic neuropathic diabetic ulcer: a phase III randomized placebo-controlled double-blind study. Diabetes Care. 1998;21822- 827Article