This Month's Clinical Focus: Ophthalmology

Inhaled and Oral Steroid Use Impacts Cataract Risk

 A study conducted by the Centre for Vision Research, University of Sydney, Australia, examines how steroid (corticosteroid) use relates to risks for cataract, the clouding of the eye's lens that leads to reduced vision and blindness, if untreated. Many people with asthma rely on inhaled, and sometimes oral, steroids, as do people with chronic obstructive pulmonary disease (COPD). This population-based study, a cohort of the Blue Mountains Eye Study, followed 3,654 Australians, aged 49 years or older, five and 10 years after initial (baseline) examinations conducted between 1992 and 1994. This timeframe was needed to assess the long-term impact of steroid use on cataracts , which develop slowly over years. Based on their findings, the researchers suggest that more judicious prescription of combined inhaled and oral steroids may decrease cataract risk for asthma patients.

 "Our findings could mean th at combined steroid use, when it results in high cumulative dosage over relatively long periods , increases risks for two types of cataract," said lead researcher, Jie Jin Wang, MMed, PhD, Centre for Vision Research. "When clinicians prescribe both steroid forms, the cumulative, combined dose should be considered. Also, recent clinical trials indicate that combined steroids are not more effective than inhaled steroids alone in treating asthma." He added that further investigation is needed to determine whether asthma plays a role in nuclear cataract development.

Elevated cataract risks were found only in patients who, at the time of their baseline exams, had ever used inhaled steroids, had also used oral steroids for at least one month, and had no cataracts. Patients at highest risk for two types of cataract were those defined at baseline as "current users" of both steroid forms; although this was a small group, follow up exams found that nearly all of them developed cataracts . Of seven current user patients, five had used either steroid form for more than five years, and four of the five developed posterior subcapsular cataract (PSC). Three additional current user patients developed nuclear cataracts. In nuclear cataracts the center of the lens is obscured, and in PSC the cataract develops in the rear area of the lens. Earlier research had established a higher risk for PSC in oral steroids users.

The Way We See It: Newsworthy and Noteworthy

 June 8, 2009  CenterWatch reported that Neurotech Pharmaceuticals issued positive results from two phase II trials of NT-501 for the treatment of retinitis pigmentosa (RP). Both trials were a multi-centered, randomized, double-masked, placebo controlled dose ranging design. The first study enrolled 65 subjects with later stage RP (diagnoses of RP and vision between 20/63 and 20/320). The second trial studied 67 subjects with earlier stage RP (diagnoses of RP and vision better than 20/63). The subjects received either high dose or low dose NT-501 in one eye and placebo in the other eye. Best corrected visual acuity (BCVA) and visual field sensitivity (VFS) were evaluated as primary endpoints for the later stage study and the earlier stage RP study, respectively. At 12 months no trend in visual benefit was observed in either study for these functions. However, in both studies, there was a statistically significant, dose-dependent increase in retinal thickness involving photoreceptor layers as measured by optical coherence tomography (p< 0.001 for the high dose group in each study). No treatment-related serious adverse events were reported and both NT-501 and the surgical procedure were well-tolerated.

 May 25, 2009  CenterWatch reported that Ista issued positive results from three phase III trials of Bepreve for the treatment of allergic conjunctivitis. The first two studies were 7-week, masked, randomized, placebo-controlled conjunctival allergen challenge (CAC) clinical studies and enrolled a total of 157 subjects who received placebo or Bepreve 1.5% in both eyes. The studies showed Bepreve 1.5% dosed in both eyes was clinically effective in reducing ocular itching associated with allergic conjunctivitis for at least 8 hours after dosing. It was statistically superior to placebo in reducing ocular itching at CAC tests conducted 15 minutes, 8 hours, and 16 hours after dosing (P<0.0001). The third study was a multi-center, double-masked, placebo-controlled design enrolled 86 subjects. The subjects were randomized to receive either Bepreve 1.5% or placebo in both eyes in three CAC tests spaced two weeks apart. The results showed Bepreve 1.5% was statistically superior to placebo for at least 8 hours after ophthalmic dosing for reducing CAC-induced tearing.  

If you want to transform your ophthalmology clinical trial, you need to change the workflow paradigm. Criterium knows resources are precious, time is the enemy, and results are paramount. Our user-friendly technologies are integrated into all aspects of our clinical development services for improved efficiencies. And a talented in-house staff that is committed to the professional support of our clients individual and particular needs is the backbone of our processes for maximum client outcomes.

Of particular interest to you would be our experience with ophthalmology studies.  Criterium has managed many ophthalmology studies, including: Lens Replacement, Immunosuppressive Therapy for Prevention of Secondary Cataracts, Glaucoma, Infectious disease, Conjunctivitis, Allergies.

Get to know us! We have several propriety technology solutions available that are proven to improve your clinical trial results. Contact John Hudak at jmhudak@criteriuminc.com