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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)

This study is currently recruiting participants.
Verified March 2013 by Novartis
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: March 27, 2013
Last verified: March 2013
History of Changes
  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:

Drug Information available for: Ranibizumab
U.S. FDA Resources

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)


Estimated Enrollment: 120
Study Start Date: December 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594281

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Locations
Germany
Novartis Investigative Site Recruiting
Aachen, Germany, 52074
Novartis Investigative Site Not yet recruiting
Augsburg, Germany, 86156
Novartis Investigative Site Not yet recruiting
Bayreuth, Germany, 95444
Novartis Investigative Site Not yet recruiting
Berlin, Germany, 13353
Novartis Investigative Site Not yet recruiting
Bremen, Germany, 28209
Novartis Investigative Site Recruiting
Chemnitz, Germany, 09116
Novartis Investigative Site Recruiting
Darmstadt, Germany, 64298
Novartis Investigative Site Not yet recruiting
Dortmund, Germany, 44137
Novartis Investigative Site Recruiting
Duesseldorf, Germany, 40225
Novartis Investigative Site Not yet recruiting
Duesseldorf, Germany, 40219
Novartis Investigative Site Recruiting
Essen, Germany, 45122
Novartis Investigative Site Recruiting
Frankfurt, Germany, 60318
Novartis Investigative Site Not yet recruiting
Frankfurt, Germany, 60590
Novartis Investigative Site Recruiting
Freiburg i. Br, Germany, 79106
Novartis Investigative Site Not yet recruiting
Göttingen, Germany, 37075
Novartis Investigative Site Recruiting
Hamburg, Germany, 22417
Novartis Investigative Site Not yet recruiting
Hamburg, Germany, 20246
Novartis Investigative Site Not yet recruiting
Hösbach, Germany, 63768
Novartis Investigative Site Not yet recruiting
Karlsruhe, Germany, 76133
Novartis Investigative Site Not yet recruiting
Karlsruhe, Germany, 76199
Novartis Investigative Site Recruiting
Kiel, Germany, 24105
Novartis Investigative Site Recruiting
Koeln, Germany, 50924
Novartis Investigative Site Not yet recruiting
Koeln, Germany, 51109
Novartis Investigative Site Recruiting
Leipzig, Germany, 04103
Novartis Investigative Site Not yet recruiting
Ludwigshafen, Germany, 67063
Novartis Investigative Site Recruiting
Marburg, Germany, 35039
Novartis Investigative Site Recruiting
Muenster, Germany, 48149
Novartis Investigative Site Recruiting
Muenster, Germany, 48145
Novartis Investigative Site Not yet recruiting
Munich, Germany, 80336
Novartis Investigative Site Recruiting
München, Germany, 81675
Novartis Investigative Site Withdrawn
Nuernberg, Germany, 90491
Novartis Investigative Site Recruiting
Recklinghausen, Germany, 45657
Novartis Investigative Site Recruiting
Regensburg, Germany, 93042
Novartis Investigative Site Recruiting
Siegburg, Germany, 53721
Novartis Investigative Site Recruiting
Tübingen, Germany, 72076
Novartis Investigative Site Recruiting
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

No publications provided

Responsible Party: Novartis ( 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: March 27, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Panretinal photocoagulation
Ranibizumab

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
 Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on May 19, 2013