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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01594281
Recruitment Status : Completed
First Posted : May 9, 2012
Results First Posted : March 15, 2019
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this study was to assess the efficacy and safety of the anti-Vascular Endothelial Growth Factor (VEGF) agent ranibizumab (0.5 mg) with or without Panretinal laser photocoagulation (PRP) compared to PRP alone in patients with Proliferative Diabetic Retinopathy (PDR).

Condition or disease Intervention/treatment Phase
Proliferative Diabetic Retinopathy (PDR) Drug: Ranibizumab 0.5 mg Procedure: Panretinal laser photocoagulation Phase 2

Detailed Description:
A 12-month core phase was followed by a 12-month observational follow-up phase (physician's routine), for a planned individual study duration of 24-25 months. A separate informed consent was signed for the 12-month observational follow-up phase. This study was conducted in Germany.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 107 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: An open-label design was chosen in which the evaluation of the primary objective was performed by a reading center. The reading center that evaluated the primary and several secondary objectives was blinded to randomization and therefore assessed these objectives uninfluenced by treatment information. However, laser burns were visible on the images, and no full blinding regarding panretinal laser photocoagulation (PRP) was possible for the reading center.
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
Actual Study Start Date : December 11, 2012
Actual Primary Completion Date : November 30, 2016
Actual Study Completion Date : December 5, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Ranibizumab

Arm Intervention/treatment
Experimental: Ranibizumab mono
Interventional Core Phase: One intravitreal injection of ranibizumab 0.5 mg to the study eye monthly until stability regarding morphological parameters is confirmed (ie, no further improvement of morphology or no worsening of morphology for 3 consecutive months)
Drug: Ranibizumab 0.5 mg
Pre-filled syringe for intravitreal injection
Other Names:
  • Lucentis®
  • RFB002

Active Comparator: PRP mono
Interventional Core Phase: Panretinal laser photocoagulation (PRP) treatment administered to the study eye in accordance with the modified diabetic retinopathy study (DRS) guidelines for panretinal laser photocoagulation procedures
Procedure: Panretinal laser photocoagulation
PRP treatment following DRS guidelines
Other Name: PRP

Experimental: Ranibizumab+PRP
Interventional Core Phase: Ranibizumab 0.5 mg as described for the ranibizumab mono arm and PRP treatment as described for the PRP mono arm until stability regarding morphological parameters is confirmed
Drug: Ranibizumab 0.5 mg
Pre-filled syringe for intravitreal injection
Other Names:
  • Lucentis®
  • RFB002

Procedure: Panretinal laser photocoagulation
PRP treatment following DRS guidelines
Other Name: PRP




Primary Outcome Measures :
  1. Change From Baseline in Area of Neovascularizations (NVs) at End of Core Study (EOCS) [ Time Frame: Baseline, EOCS ]
    The area of neovascularizations (NV) was assessed by a central reading center via fluorescein angiography (FA) images. The area of NV was calculated as the sum of area of neovascularization of the disc (NVD) and neovascularization elsewhere (NVE) and was recorded in square millimeters. A higher positive change value may indicate a greater formation of new, abnormal blood vessels and thus disease progression. One eye (study eye) contributed to the analysis.


Secondary Outcome Measures :
  1. Change From Baseline in Area of Neovascularizations (NVs) at Month 3 [ Time Frame: Baseline, Month 3 ]
    The area of neovascularizations (NV) was assessed by a central reading center via fluorescein angiography (FA) images. The area of NV was calculated as the sum of area of neovascularization of the disc (NVD) and neovascularization elsewhere (NVE) and was recorded in square millimeters. A higher positive change value may indicate a greater formation of new, abnormal blood vessels and thus disease progression. One eye (study eye) contributed to the analysis.

  2. Best Corrected Visual Acuity (BCVA) (ETDRS Letters) at EOCS [ Time Frame: EOCS ]
    BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at a testing distance of 4 meters. A higher number of ETDRS letters may indicate better visual acuity. One eye (study eye) contributed to the analysis.

  3. Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS [ Time Frame: Baseline, EOCS ]
    BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts at a testing distance of 4 meters. No clinically relevant change was defined as <5 letters gain or loss. A higher positive change value may indicate a greater improvement in visual acuity. One eye (study eye) contributed to the analysis.

  4. Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS [ Time Frame: Baseline, EOCS ]
    The severity level of diabetic retinopathy was determined using the ETDRS severity scale. However, in contrast to the original ETDRS severity scale, wide field fluorescein angiography images were used in addition to color fundus photography for identification of NVs and prior PRP treatment was not considered for determining the severity level. Eyes could be graded in the following classes: "DR absent" (10), "questionable DR" (14,15), "NPDR" (20-53), "mild PDR" (60-61), "moderate PDR" (65), "high risk PDR" (71-75), "advanced PDR" (81-85) and "cannot grade" (90). One eye (study eye) contributed to the analysis. No statistical analysis was conducted for ≥ 1 class deterioration or ≥ 2 class deterioration from Baseline at EOCS because ratios could not be calculated in case of zero frequencies in at least one of the three treatment groups.

  5. Change From Baseline in Central Subfield Thickness at EOCS [ Time Frame: Baseline, EOCS ]
    Central subfield retinal thickness was assessed by a central reading center using Optical Coherence Tomography images. A positive change value may indicate disease progression. One eye (study eye) contributed to the analysis.

  6. Change From Baseline in Foveal Center Point Retinal Thickness at EOCS [ Time Frame: Baseline, EOCS ]
    Foveal center point retinal thickness was assessed by a central reading center using Optical Coherence Tomography images. A positive change value may indicate disease progression. One eye (study eye) contributed to the analysis.

  7. Number of Ranibizumab Injections Until EOCS [ Time Frame: Baseline to EOCS ]
    The total number of ranibizumab injections until EOCS was calculated. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.

  8. Number of PRP Laser Spots Until EOCS [ Time Frame: Baseline to EOCS ]
    The total number of PRP laser spots from baseline until EOCS was calculated. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Proliferative Diabetic Retinopathy
  • Best Corrected Visual Acuity (BCVA) in study eye of at least 20 Early Treatment Diabetic Retinopathy Study (ETDRS) letters (20/400)
  • Type 1 or type 2 diabetes under medical surveillance / with stabilized treatment

Exclusion Criteria:

  • Proliferative vitreoretinopathy in study eye
  • Clinically significant macular edema (CSME) in the study eye
  • Clinically non significant macular edema (CNSME) that is likely to develop to CSME in the study eye
  • Uncontrolled glaucoma in either eye
  • Other protocol-specified conditions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594281


Locations
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Germany
Novartis Investigative Site
Aachen, Germany, 52074
Novartis Investigative Site
Augsburg, Germany, 86156
Novartis Investigative Site
Berlin, Germany, 12203
Novartis Investigative Site
Darmstadt, Germany, 64297
Novartis Investigative Site
Duesseldorf, Germany, 40225
Novartis Investigative Site
Essen, Germany, 45122
Novartis Investigative Site
Freiburg, Germany, 79106
Novartis Investigative Site
Glauchau, Germany, 08371
Novartis Investigative Site
Gottingen, 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
Muenchen, Germany, 81675
Novartis Investigative Site
Muenster, Germany, 48145
Novartis Investigative Site
Muenster, Germany, 48149
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
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01594281    
Other Study ID Numbers: CRFB002DDE21
2011-005542-35 ( EudraCT Number )
First Posted: May 9, 2012    Key Record Dates
Results First Posted: March 15, 2019
Last Update Posted: March 15, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Panretinal photocoagulation
Ranibizumab
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents