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Behind the Lab Door

Trials from University Hospital Basel; General Hospital Linz; St. Gallen Hospital; and QLT Inc.

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Intraoperative utility of brilliant blue G (BBG) and indocyanine green (ICG) assisted chromovitrectomy

Institution: University Hospital Basel; General Hospital Linz; St. Gallen Hospital

Principal investigator: Paul B. Henrich, MD

Abstract/statement of the trial’s goals:

Intravitreal dyes are intended to make the surgical extraction of the internal limiting membrane (ILM) safer and more complete. However, the search for an adequate vital dye is ongoing. The most commonly used vital dye is indocyanine green (ICG), although it is not approved for intravitreal use and has been associated with ocular toxicity. The reason for its continued popularity seems to be that it stains the ILM better than the approved and less toxic alternative substances brilliant blue G (BBG) and trypan blue (TB). According to anecdotal reports from surgeons, another reason for ICG’s popularity may be the fact that it seems to make ILM removal easier. Ultimately, the intention of the investigators’ research is to identify possible modifications to existing dyes to reach improved intraoperative dye utility combined with a favorable safety profile.

ClinicalTrials.gov identifier: NCT01485575

Inclusion criteria:

• Older than 18 years of age
• No other chromovitrectomy in previous 6 months
• Only one of three vital dyes used intraoperatively (BBG, ICG or TB)

Exclusion criteria:

• Previous chromovitrectomy during last 6 months
• Pregnant patients
• Patients younger than 18 years of age

Enrollment status: Active, enrolling participants at all study locations:

• General Hospital Linz, Linz, Austria, 4010
• University of Basel, Basel, BS, Switzerland, 4056
• St. Gallen Hospital, St. Gallen, SG, Switzerland, 9007

Safety/proof of concept study of oral QLT091001 in subjects with Leber’s congenital amaurosis (LCA) or retinitis pigmentosa (RP) due to retinal pigment epithelial 65 protein (RPE65) or lecithin:retinol acyltransferase (LRAT) mutations

Institution: QLT Inc.

Author/principal investigator: Suzanne Cadden

Abstract/statement of the trial’s goals:

The purpose of this study is:

• to evaluate the safety of oral QLT091001
• to evaluate whether 7-day treatment with oral QLT091001 can improve visual function in subjects with LCA or RP due to RPE65 or LRAT mutations
• to evaluate duration of visual function improvement (if observed)

ClinicalTrials.gov identifier: NCT01014052

Inclusion criteria:

• Subjects diagnosed with LCA or RP (with a mutation in either RPE65 or LRAT)
• Subjects with LCA must be 5 to 65 years of age
• Subjects with RP must be 18 to 65 years of age
• Subjects who have a best corrected visual acuity of three letters or better (20/800 Snellen equivalent) or viable photoreceptors on OCT/FAF.

Exclusion criteria:

• Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 60 days of day 0.
• Subjects with any clinically important abnormal physical finding at screening.
• Subjects who have taken any prescription or investigational oral retinoid medication (eg, Accutane, Soriatane) within 6 months of day 0 and subjects who did not tolerate their previous oral retinoid medication will be excluded regardless of the time of last exposure.
• Subjects with a history of diabetes or chronic hyperlipidemia, hepatitis, pancreatitis or cirrhosis.
• Subjects who have taken any supplements containing 10,000 IU vitamin A or more within 60 days of screening

Enrollment status: Currently recruiting participants in all study locations:

• The Chicago Lighthouse for People Who Are Blind or Visually Impaired, The Pangere Center For Inherited Retinal Diseases, Chicago, IL 60608
• Wilmer Eye Institute, Johns Hopkins University, Baltimore, MD 21287
• Scheie Eye Institute, Philadelphia, PA 19104
• Montreal Children’s Hospital, McGill University Health Centre, Montreal, Quebec, H3H 1P3
• Institute for Ophthalmic Research, University of Tubingen, Tubingen, Germany
• The Rotterdam Eye Hospital, Rotterdam, Netherlands
• Moorefield Eye Hospital, London, UK EC1 V2PD