Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2016-001680-37-ES
EUCTR2016-001680-37-ES
Active, not recruiting
Phase 1

A prospective, non-randomised, multicenter study on the efficacy and safety of ILUVIEN® in diabetic macular edema patients considered insufficiently responsive to available therapies (REACT) - REACT

Dr. José Maria Ruiz Moreno0 sitesAugust 11, 2016
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
DrugsIluvien

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Dr. José Maria Ruiz Moreno
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 11, 2016
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Dr. José Maria Ruiz Moreno

Eligibility Criteria

Inclusion Criteria

  • •1\.Patients \=18 years of age, of either sex that have signed informed consent.
  • •2\.DME based on investigator’s clinical evaluation and demonstrated using fundoscopic photography and SD\-OCT.
  • •3\.Patients considered as insufficiently responsive as defined as having underwent other previous treatments, including at least 3 anti\-VEGF injections in the last 6 months and/or corticoesteroids injections 6 months ago or more, and meet the following:
  • •\-Mean central foveal thickness (central subfield thickness) \= 290 µm in women and \= 305 µm in men in Zeiss Cirrus OR \= 305µm in women and \= 320 µm in men in Heidelberg Spectralis, or equivalent accordingly with Tocon or Swep Source, in the study eye as measured using SD\-OCT;
  • •\-Vision impairment (20/50 to 20/400 using Snellen visual acuity equivalent) related to DME;
  • •\-If in the Investigator’s opinion a further improvement is possible.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 30

Exclusion Criteria

  • •1\.IOP \> 21 mmHg at screening in the study eye.
  • •2\.Historical rise in IOP \> 25 mmHg following treatment with an intravitreal corticosteroid in the study eye.
  • •3\.Use of \= 2 active agents as IOP\-lowering medications to control IOP at screening in the study eye.
  • •4\.Patients that have vitreomacular traction in DME and opaque media in the study eye.
  • •5\.Patients with severe proliferative diabetic retinopathy requiring pan retinal photocoagulation in the study eye.
  • •6\.Pregnant or child\-bearing potential women who do not want to use contraception methods during the study period.
  • •7\.Patients diagnosed with active angiographic central macular ischaemia prior to screening in the study eye.
  • •8\.Patients that have received pan retinal photocoagulation or undergone cataract surgery in the 3 months prior to the screening visit in the study eye.
  • •9\.Patients with contraindications:
  • •a.Presence of pre\-existing glaucoma.

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Not Applicable
A Prospective, Non-randomized, Multicenter Study of the Efficacy of Adhesion Barriers in Laparoscopic Surgery for Colorectal Cancer in JapaColorectal Cancer
JPRN-UMIN000035144Department of Clinical Oncology, Kawasaki Medical School452
Completed
Phase 4
R3 Acetabular Hip system in patients with degenerative joint disease.Degenerative joint disease.Musculoskeletal - Other muscular and skeletal disorders
ACTRN12608000234314Smith & Nephew70
Completed
Not Applicable
A Prospective, Multi-Center, Non-Randomized Study of the BD Bard COVERA™ PLUS Vascular Covered Stent in the Treatment of Iliac Artery DiseaseTreatment of stenoses and occlusions in common/external iliac arteriesI73.9Peripheral vascular disease, unspecified
DRKS00017906BD, Angiomed GmbH & Co. Medizintechnik KG101
Completed
Not Applicable
An observational multicenter study comparing Tenecteplase assisted Percutaneous Coronary Intervention (PCI) versus primary PCI in Indian patients with ST elevation Myocardial InfarctioHealth Condition 1: null- Patients with acute STEMI who are to be treated with primary PCI/pharmacoinvasive therapy within 12 hours of symptoms onset will be included.
CTRI/2011/08/001950STEMI India Charitable Trust200
Completed
Not Applicable
A multicenter, prospective, observational study for the association serum pancreatic enzyme level and CT image findings in post-ERCP pancreatitisPost-ERCP pancreatitis
JPRN-UMIN000024814Department of Gastroenterology, Kyoto Second Red Cross Hospital5,000