Monthly Archives: May 2022
Dermapliq – Regenerating matrix-based therapy for chronic wound healing
Suzanne L Groah, Alexander Libin, Miriam Spungen, Kim-Loan Nguyen, Earthaleen Woods, Marjan Nabili, Jessica Ramella-Roman, Denis Barritault
The aim of this study was to determine whether a skin-specific bioengineered regenerating agent (RGTA) heparan sulphate mimetic (CACIPLIQ20) improves chronic wound healing. The design of this article is a prospective within- subject study. The setting was an urban hospital. Patients were 16 African-American individuals (mean age 42 years) with 22 wounds (mean duration 2·5 years) because of either pressure, diabetic, vascular or burn wounds. Two partic- ipants each were lost to follow-up or removed because of poor compliance, resulting in 18 wounds analysed. Sterile gauze was soaked with CACIPLIQ20 saline solution, placed on the wound for 5 min, then removed twice weekly for 4 weeks. Wounds were otherwise treated according to the standard of care. Twenty-two percent of wounds fully healed during the treatment period. Wounds showed a 15·2–18·1% decrease in wound size as measured by the vision engineering research group (VERG) digital wound measurement system and total PUSH scores, respectively, at 4 weeks (P = 0·014 and P = 0·003). At 8 weeks there was an 18–26% reduction in wound size (P = 0·04) in the remaining patients. Wound-related pain measured by the visual analogue pain scale and the wound pain scale declined 60% (P = 0·024) and 70% (P = 0·001), respectively. Patient and clinician satisfaction remained positive throughout the treatment period. It is concluded that treatment with CACIPLIQ20 significantly improved wound- related pain and may facilitate wound healing. Patient and clinician satisfaction remained high throughout the trial.
Clerapliq – Jama Ophtalmology clinical trial
Ahmed M Bata , Katarzyna J Witkowska , Piotr A Wozniak , Klemens Fondi , Gerald Schmidinger , Niklas Pircher , Stephan Szegedi , Valentin Aranha Dos Santos , Anca Pantalon , René M Werkmeister, Gerhard Garhofer , Leopold Schmetterer, Doreen Schmidl
Importance: Corneal abrasions are frequent after standard (epithelium-off [epi-off]) corneal collagen cross-linking (CXL) in patients with progressive keratoconus. A new matrix therapy agent (ReGeneraTing Agent [RGTA]) has been developed to promote corneal wound healing.
Objective: To assess the effect of the new type of matrix therapy agent on corneal wound healing after epi-off CXL in patients with keratoconus.
Design, setting, and participants: This double-masked randomized clinical trial enrolled 40 patients with keratoconus undergoing epi-off CXL from July 18, 2014, to October 21, 2015, when the last follow-up was completed. The analysis of the intention-to-treat population was performed at the Department of Clinical Pharmacology in cooperation with the Center for Medical Physics and Biomedical Engineering and the Department of Ophthalmology and Optometry of the Medical University of Vienna.
Interventions: Patients were randomized to receive the matrix therapy agent or hyaluronic acid-containing eyedrops, 0.1%, every other day starting immediately after surgery. The size of the corneal defect was measured using ultrahigh-resolution optical coherence tomography (OCT) and slitlamp photography (SLP) with fluorescein staining.
Main outcomes and measures: Corneal wound healing rate, defined as the size of the defect over time.
Results: Among the 40 patients undergoing epi-off CXL (31 men; 9 women; mean [SD] age, 31  years), wound healing was significantly faster in the matrix therapy agent group compared with the hyaluronic acid group (4.4 vs 6.1 days; mean difference, 1.7 days; 95% CI, 0.25-3.15 days; P = .008). The defect size was smaller in the matrix therapy agent group than in the hyaluronic acid group as measured with OCT (12.4 vs 23.9 mm2; mean difference, 11.6 mm2; 95% CI, 0.8-23.5 mm2; P = .045) and SLP (11.9 vs 23.5 mm2; mean difference, 11. 6 mm2; 95% CI, 1.3-22.9 mm2; P = .03). A correlation between the defect size measured with OCT and SLP was found (r = 0.89; P < .001). No ocular or serious adverse events occurred.
Conclusions and relevance: Use of a new matrix therapy agent appears to improve corneal wound healing after CXL in patients with keratoconus. Monitoring of corneal wound healing using ultrahigh-resolution OCT might be an attractive alternative to SLP because OCT provides an objective and 3-dimensional evaluation of the corneal defect.
Trial registration: clinicaltrials.gov Identifier: NCT02119039.
Clerapliq – Topical Treatment with a New Matrix Therapy Agent
Abdelouahab Aifa, Julie Gueudry, Alexandre Portmann, Agn`es Delcampe, and Marc Muraine
PURPOSE. Neurotrophic keratopathy is a degenerative disease of the corneal epithelium resulting from impaired corneal innervation, possibly leading to perforation. We aimed to assess the efficacy and tolerance of a new matrix therapy agent (RGTA, Cacicol20), mimicking heparan sulfates, for the management of neurotrophic keratopathy.
METHODS. We carried out an uncontrolled, prospective, single- center clinical study on 11 patients (11 eyes) with severe corneal neurotrophic ulcers, despite the use of preservative- free artificial tears, for 15 days. Patients were treated with RGTA eye drops, instilled at a dosage of one drop in the morning, on alternate days. Evolution and follow-up during treatment were evaluated by slit-lamp examination, photogra- phy, fluorescein-dye testing, tests of corneal sensitivity, and best corrected visual acuity. The main outcome measures for each patient were healing of the corneal surface and best corrected visual acuity before and after RGTA therapy.
RESULTS. Eight patients displayed complete corneal healing after a mean period of 8.7 weeks (range; 1 to 22 weeks). Mean ulcer area decreased significantly, from 11.12% to 6.37% (P 1⁄4 0.048) in the first week, and to 1.56% (P 1⁄4 0.005) at 1 month. Treatment failure was observed in three cases, requiring amniotic membrane transplantation in two patients and penetrating keratoplasty in one patient. At the end of the study, none of the patients displayed significant improvement in visual acuity. There were no systemic or local side effects of treatment.
CONCLUSIONS. RGTA seems to be a potentially useful, alternative, noninvasive therapeutic approach in neurotrophic keratopathy management. However, randomized studies are necessary.
Clerapliq -Prise en charge médicale des ulcères cornéens avec RGTA
Cas clinique – L’Essentiel
Bertrand Michaud – Docteur vétérinaire
Les ulcères cornéens sont des affections fréquemment rencontrées en pratique vétérinaire quotidienne. Leur trai- tement passe par la mise en évidence de l’origine de la lésion. Ainsi, le traitement devra être adapté à la cause, il n’y a pas de recette pré-établie, seul le sens clinique du praticien et un suivi régulier permettront de traiter correc- tement l’ulcère.
Une nouvelle classe de molécules est récemment appa- rue dans le traitement des ulcères cornéens et de la cica- trisation des tissus en général, les RGTA (ReGeneraTing Agents – Clerapliq®). Nous expliquerons les modalités d’action de l’OTR4120 et son intérêt en les illustrant par trois cas cliniques.