Nal-IRI plus 5-FU/LV and Nab-Paclitaxel plus Gemcitabine alternately every two months
Nal-IRI at 80 mg/m2 IV over 90 minutes followed by folinic acid (leucovorin 400 mg/m2 IV, or Elvorin 200 mg/m2 IV over 30 minutes) then by 5-FU 2400 mg/m2 IV over 46-hours, every 2 weeks.
Nab-Paclitaxel + Gemcitabine (6 injections, one injection three weeks out of four; so ≈ 2 months per cycle)
Day 1 (D1): Nab-Paclitaxel plus Gemcitabine at the dose of :
Gemcitabine: 1000 mg/m² in 500 ml normal saline infusion at a fixed dose rate of 10 mg/m²/min (i.e. 100 min).
Nab-Paclitaxel: 125 mg/m2 This treatment is administered at D1, D8, D15 and at D29, D36, D43.

Nal-IRI plus 5-FU/LV Nal-IRI at 80 mg/m2 IV over 90 minutes followed by folinic acid (leucovorin 400 mg/m2 IV, or Elvorin 200 mg/m2 IV over 30 minutes) then by 5-FU 2400 mg/m2 IV over 46-hours, every 2 weeks.

Nab-Paclitaxel plus Gemcitabine Nab-Paclitaxel + Gemcitabine (6 courses, one course three weeks out of four; so ≈ 2 months per cycle)
Day 1 (D1): Nab-Paclitaxel + Gemcitabine at the dose of :
Gemcitabine: 1000 mg/m² in 500 ml normal saline infusion at a fixed dose rate of 10 mg/m²/min (i.e. 100 min).
Nab-Paclitaxel: 125 mg/m2 This treatment is administered at D1, D8, D15 and at D29, D36, D43.

Metastatic Pancreatic Cancer

Irinotecan Liposomal Injection

5-FU 2400 mg/m2 IV over 46-hours, every 2 weeks.

5-FU/LV

Nab-Paclitaxel: 125 mg/m2 This treatment is administered at D1, D8, D15 and at D29, D36, D43.

Nab-Paclitaxel

1000 mg/m² in 500 ml normal saline infusion at a fixed dose rate of 10 mg/m²/min (i.e. 100 min). This treatment is administered at D1, D8, D15 and at D29, D36, D43.

Gemcitabine

Clinique privée de l'Europe

CHU Hôtel Dieu

Hôpital privé

CH de la Côte Basque

CHU Avicenne

CH Duchenne

Hôpital Privé Sainte Marie

CHU Estaing

Hopitaux civils de Colmar

CH Sud Francilien

Centre GF Leclerc

Institut de cancérologie de Bourgogne

Hôpital Emile Roux

CH Docteur Schaffner

CHU Dupuytren

Clinique privée Jean Mermoz

Hôpital Européen

Institut Paoli Calmettes

Centre médical Oncogard

CH Privé Sainte Marie

Groupe Hospitalier La Pitié Salpêtrière

Hôpital Cochin

Hôpital Tenon

Hopital Européen Georges Pompidou

CH Saint Jean

Centre Cario HPCA

CH Jacques Puel

CHU Charles Nicolle

CH Foch

CHRU de Nancy

CHU Clarac

First Line Metastatic Pancreatic Cancer : 5FU/LV+Nal-IRI, Gemcitabine+Nab-paclitaxel or a Sequential Regimen of 2 Months 5FU/LV+Nal-IRI

Randomized Phase II Study Comparing 5FU/LV+Nal-IRI, Gemcitabine+Nab-paclitaxel or a Sequential Regimen of 2 Months 5FU/LV+Nal-IRI Followed by Two Months of Gemcitabine+Nab-paclitaxel, in Metastatic Pancreatic Cancer

PFS is defined as the time between the date of randomization and the date of the first radiological and/or clinical progression or the date of death (for whatever reason). Patients living without progression will be censured at date of last news. Progression is assessed by investigator and central review according to RECIST v1.1 criteria.

BOR is defined as complete or partial response rate according to scans and RECIST v1.1 criteria over the entire treatment period.

OS is defined as the time between the date of randomization and the date of death (whatever the cause). Alive patients will be censured at date of last news.

Time to treatment failure is defined as the time between the date of randomization and the date of discontinuation of all protocol treatments (regardless of cause) or date last news for patients alive under treatment.

Toxicities are evaluated according to NCI-CTC v4.0.

Federation Francophone de Cancerologie Digestive

Glaucoma Eye

The XEN gel stent (Allergan, Dublin, Ireland) is a recently developed, permanent, ab interno collagen implant that reduces IOP by draining aqueous fluid from the anterior chamber into the subconjunctival space

XEN45 gel stent implantation in glaucoma surgery

An Innovation in Glaucoma Surgery: XEN45 Gel Stent Implantation

XEN45 Gel Stent Implantation in Glaucoma Surgery

Mean number of antiglaucomatous medications

This clinical trial is under review for publishing. If it is accepted for publishing,our results will be shared.

Sadık Altan Ozal

Ass. Proff, M.D.

Trakya University

Simultaneous combined transepithelial photorefractive keratectomy (TransPRK) and corneal collagen cross-linking (CXL)

Corneal collagen cross-linking (CXL) using the same protocol without transepithelial photorefractive keratectomy

Simultaneous combined transepithelial photorefractive keratectomy (TransPRK) and corneal collagen cross-linking (CXL)
Transepithelial Photorefractive Keratectomy (TransPRK): Aberrometry or topography guided transepithelial photorefractive keratectomy (TransPRK) using the Schwind Amaris 750s excimer laser (www.eye-tech-solutions.com), an 8mm treatment diameter, and a tissue saving algorithm targeting selected higher order aberrations only. TransPRK will be followed immediately by corneal collagen cross-linking (CXL).
Corneal Collagen Cross-Linking (CXL): Riboflavin soak: 10 minutes total soak time; application of 0.1% riboflavin preparation (VibeX Rapid - www.avedro.com) each 2 minutes with gentle balanced salt solution irrigation to remove excess riboflavin prior to UV light exposure.
UV light exposure: Total treatment time 8 minutes (370nm wavelength; 30mW/cm2 irradiance; 4 minutes total UV exposure time, pulsed 1.5 seconds on 1.5 seconds off; Avedro KXL I light source)

TransPRKCXL

Corneal collagen cross-linking (CXL), manual corneal epithelial removal, no excimer laser treatment
CXL protocol was identical in both study arms. After corneal epithelial removal, a 10 minute soak with Vibex rapid (www.avedro.com) was followed by 8 minutes pulsed UV light using a uniform beam source (KXL - www.avedro.com) and a 1.5 second on/off cycle (7.2mJ/cm2 total energy @ 30mW/cm2 irradiance).

CXL Only

Total

Sex: Female, Male

Region of Enrollment

Change in spectacle corrected logarithm minimum angle of resolution (LogMAR) distance visual acuity recorded in a 4m testing lane in photopic lighting conditions between baseline measurement and final review at 24 months (note that negative change = better vision; 0.1 logMAR units = 1 line on the test chart)

CXL only (no PRK) using manual corneal epithelial removal and the same accelerated pulsed protocol as used in the TransPRK group

Change in LogMAR Corrected Distance Visual Acuity (CDVA)

Number of participants with gain of ≥2 lines (≥0.20 logMAR units) corrected distance visual acuity (CDVA) on a standard 5 letter per line EDTRS visual acuity testing chart

Clinically Significant Visual Gain

Number of participants with loss of ≥2 lines (≥0.20 LogMAR units) corrected distance visual acuity (CDVA)

Clinically Significant Visual Loss

Pentacam (www.oculus.de) measure: Maximum local curvature (Kmax). Reduction in dioptric value = corneal flattening

Change in Kmax - Maximum Local Anterior Corneal Surface Curvature on Tomography Map

The number of participants with possible keratoconus disease progression after treatment defined by a ≥1.5D increase in Kmax, anterior and posterior K2 (maximum local corneal curvature, maximum anterior and posterior meridional corneal curvature) measured using a Pentacam HD corneal tomographer (www.oculus.de).

Progression Rate

Patients treated with standard accelerated corneal collagen cross-linking (historical controls)

Overall Study

Mr Bruce Allan

Standard accelerated corneal collagen cross-linking (historical controls)
Corneal Collagen Cross-Linking (CXL): Riboflavin soak: 10 minutes total soak time; application of 0.1% riboflavin preparation (VibeX Rapid - www.avedro.com) each 2 minutes with gentle balanced salt solution irrigation to remove excess riboflavin prior to UV light exposure.
UV light exposure: Total treatment time 8 minutes (370nm wavelength; 30mW/cm2 irradiance; 4 minutes total UV exposure time, pulsed 1.5 seconds on 1.5 seconds off; Avedro KXL I light source)

Keratoconus

Aberrometry or topography guided transepithelial photorefractive keratectomy (TransPRK) using the Schwind Amaris 750s excimer laser (www.eye-tech-solutions.com), an 8mm treatment diameter, and a tissue saving algorithm targeting selected higher order aberrations only. TransPRK will be followed immediately by corneal collagen cross-linking (CXL).

Transepithelial Photorefractive Keratectomy (TransPRK)

Riboflavin soak: 10 minutes total soak time; application of 0.1% riboflavin preparation (VibeX Rapid - www.avedro.com) each 2 minutes with gentle balanced salt solution irrigation to remove excess riboflavin prior to UV light exposure.
UV light exposure: Total treatment time 8 minutes (370nm wavelength; 30mW/cm2 irradiance; 4 minutes total UV exposure time, pulsed 1.5 seconds on 1.5 seconds off; Avedro KXL I light source)

Corneal Collagen Cross-Linking (CXL)

Moorfields Eye Hospital NHS Foundation Trust, 162 City Road

Simultaneous TransPRK and Corneal Collagen Cross-Linking

A Prospective Trial of Simultaneous Combined Transepithelial Photorefractive Keratectomy and Corneal Collagen Cross-linking for Keratoconus

Bruce Allan

Consultant Ophthalmic Surgeon

Moorfields Eye Hospital NHS Foundation Trust

Interventional case series with matched historical controls

Trabeculectomy with mitomycin C associated with 2 subconjunctival injections of ranibizumab: 1 intraoperatively and 1 at 2 weeks post-operatively

Trabeculectomy with mitomycin C and standard post-operative care

Glaucoma

Two ranibizumab subconjunctival injections (0.5 mg ∕ 0.05 mL). The first injection at the end of the surgery (intraoperative) and the second two weeks post-operatively.

ranibizumab

standard post-operative care after trabeculectomy with mitomycin C

standard care

Maisonneuve-Rosemont Hospital

Trabeculectomy With Mitomycin C Associated With Sub-conjunctival Injection of Ranibizumab

Complete success: post-operative IOP between 5-18 mm Hg and at least a 20% reduction in IOP from baseline without the use of glaucoma medications. Qualified success: similar definition with the use of glaucoma medications.

mitomycin c/atrophy

First Line Metastatic Pancreatic Cancer : 5FU/LV+Nal-IRI, Gemcitabine+Nab-paclitaxel or a Sequential Regimen of 2 Months 5FU/LV+Nal-IRI

An Innovation in Glaucoma Surgery: XEN45 Gel Stent Implantation

Simultaneous TransPRK and Corneal Collagen Cross-Linking

Trabeculectomy With Mitomycin C Associated With Sub-conjunctival Injection of Ranibizumab

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