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Multicenter 12 Months Clinical Study to Evaluate Efficacy and Safety of Ranibizumab Alone or in Combination With Laser Photocoagulation vs. Laser Photocoagulation Alone in Proliferative Diabetic Retinopathy (PRIDE) (PRIDE)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Cologne Image Reading Center & Laboratory (CIRCL)
Spranger Laboratories
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01594281
First received: May 3, 2012
Last updated: July 18, 2016
Last verified: July 2016
  Purpose
This study will assess the efficacy and safety of Ranibizumab alone or in combination with laser treatment vs. laser treatment alone in Proliferative Diabetic Retinopathy. Efficacy will be primarily measured by the change of area of neovascularizations as measured by Fluorescein Angiography at month 12 (difference to baseline value).

Condition Intervention Phase
Proliferative Diabetic Retinopathy (PDR)
Drug: Ranibizumab
Procedure: Laser photocoagulation
Procedure: Ranibizumab & laser photocoagulation
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter Randomized Open-label Three-arms Controlled 12 Months Clinical Proof of Concept Study to Evaluate Efficacy and Safety of Ranibizumab Alone or in Combination With Laser Photocoagulation vs. Laser Photocoagulation Alone in Proliferative Diabetic Retinopathy

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change of area of neovascularizations as measured by Fluorescein [ Time Frame: baseline and month 12 ] [ Designated as safety issue: No ]
    Area of NVs will be measured via FLA images by Reading Cente


Secondary Outcome Measures:
  • BCVA in all patients (ETDRS letters) [ Time Frame: baseline and month 12 ] [ Designated as safety issue: No ]
    Best corrected visual acuity (BCVA) will be measured using standardized ETDRS charts

  • Change in classification of DR based on the ETDRS severity scale (assessed by FP) [ Time Frame: baseline, month 3 and month 12 ] [ Designated as safety issue: No ]
    Reading Center will evaluate severity scale using Fundus Photography images

  • Change in retinal thickness (OCT) [ Time Frame: baseline, month 3 and month 12 ] [ Designated as safety issue: No ]
    Central retinal thickness will be measured using OCT images graded by Reading Center

  • Rates of patients (%) [ Time Frame: baseline, month 3 and month 12 ] [ Designated as safety issue: No ]
    with ≥ 5/10/15 ETDRS letters gain -with no clinical relevant change (less than 5 letters gain or loss, "stable visual acuity") -with ≥ 5/10/15 ETDRS letters loss -with improvement in BCVA (ETDRS letters)


Enrollment: 107
Study Start Date: December 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranibizumab Drug: Ranibizumab
Active Comparator: Laser photocoagulation Procedure: Laser photocoagulation
Experimental: Ranibizumab & laser photocoagulation Procedure: Ranibizumab & laser photocoagulation

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Proliferative Diabetic Retinopathy
  • BCVA ≥ 20 ETDRS letters
  • Diabetes mellitus with HbA1c ≤ 12% (=107 mmol/mol)

Exclusion Criteria:

  • Proliferative vitreoretinopathy
  • Clinically significant macular edema (CSME)
  • Clinically non significant macular edema likely to develop to CSME
  • NVD ≥ 2 DA or multiple NVE with a combined area of ≥ 2 DA involving the macula
  • Vitreous hemorrhage
  • Vitreomacular traction
  • Previous scattered PRP treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01594281

Locations
Germany
Novartis Investigative Site
Aachen, Germany, 52074
Novartis Investigative Site
Augsburg, Germany, 86156
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Darmstadt, Germany, 64297
Novartis Investigative Site
Duesseldorf, Germany, 40225
Novartis Investigative Site
Essen, Germany, 45122
Novartis Investigative Site
Freiburg i. Br, Germany, 79106
Novartis Investigative Site
Glauchau, Germany, 08371
Novartis Investigative Site
Göttingen, Germany, 37075
Novartis Investigative Site
Hamburg, Germany, 20246
Novartis Investigative Site
Hösbach, Germany, 63768
Novartis Investigative Site
Karlsruhe, Germany, 76133
Novartis Investigative Site
Koeln, Germany, 51109
Novartis Investigative Site
Leipzig, Germany, 04103
Novartis Investigative Site
Mainz, Germany, 55131
Novartis Investigative Site
Marburg, Germany, 35039
Novartis Investigative Site
Muenster, Germany, 48145
Novartis Investigative Site
Muenster, Germany, 48149
Novartis Investigative Site
Munchen, Germany, 81675
Novartis Investigative Site
München, Germany, 80336
Novartis Investigative Site
Regensburg, Germany, 93042
Novartis Investigative Site
Tübingen, Germany, 72076
Novartis Investigative Site
Ulm, Germany, 89075
Sponsors and Collaborators
Novartis Pharmaceuticals
Cologne Image Reading Center & Laboratory (CIRCL)
Spranger Laboratories
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01594281     History of Changes
Other Study ID Numbers: CRFB002DDE21  2011-005542-35 
Study First Received: May 3, 2012
Last Updated: July 18, 2016
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Panretinal photocoagulation
Ranibizumab

Additional relevant MeSH terms:
Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on September 23, 2016