NCT01594281

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Dec 2012

Longer than P75 for phase_2

Geographic Reach
1 country

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 9, 2012

Completed
7 months until next milestone

Study Start

First participant enrolled

December 11, 2012

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 5, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

March 15, 2019

Completed
Last Updated

March 15, 2019

Status Verified

November 1, 2018

Enrollment Period

4 years

First QC Date

May 3, 2012

Results QC Date

November 19, 2018

Last Update Submit

November 20, 2018

Conditions

Proliferative Diabetic Retinopathy (PDR)

Keywords

Panretinal photocoagulationRanibizumab

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Area of Neovascularizations (NVs) at End of Core Study (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.

    Baseline, EOCS

Secondary Outcomes (8)

  • Change From Baseline in Area of Neovascularizations (NVs) at Month 3

    Baseline, Month 3

  • Best Corrected Visual Acuity (BCVA) (ETDRS Letters) at EOCS

    EOCS

  • Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS

    Baseline, EOCS

  • Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS

    Baseline, EOCS

  • Change From Baseline in Central Subfield Thickness at EOCS

    Baseline, EOCS

  • +3 more secondary outcomes

Study Arms (3)

Ranibizumab mono

EXPERIMENTAL

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

PRP mono

ACTIVE COMPARATOR

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

Ranibizumab+PRP

EXPERIMENTAL

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 mgProcedure: Panretinal laser photocoagulation

Interventions

Ranibizumab 0.5 mgDRUG

Pre-filled syringe for intravitreal injection

Also known as: Lucentis®, RFB002
Ranibizumab monoRanibizumab+PRP
Panretinal laser photocoagulationPROCEDURE

PRP treatment following DRS guidelines

Also known as: PRP
PRP monoRanibizumab+PRP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Novartis Investigative Site

Aachen, 52074, Germany

Location

Novartis Investigative Site

Augsburg, 86156, Germany

Location

Novartis Investigative Site

Berlin, 12203, Germany

Location

Novartis Investigative Site

Cologne, 51109, Germany

Location

Novartis Investigative Site

Darmstadt, 64297, Germany

Location

Novartis Investigative Site

Düsseldorf, 40225, Germany

Location

Novartis Investigative Site

Essen, 45122, Germany

Location

Novartis Investigative Site

Freiburg im Breisgau, 79106, Germany

Location

Novartis Investigative Site

Glauchau, 08371, Germany

Location

Novartis Investigative Site

Göttingen, 37075, Germany

Location

Novartis Investigative Site

Hamburg, 20246, Germany

Location

Novartis Investigative Site

Hösbach, 63768, Germany

Location

Novartis Investigative Site

Karlsruhe, 76133, Germany

Location

Novartis Investigative Site

Leipzig, 04103, Germany

Location

Novartis Investigative Site

Mainz, 55131, Germany

Location

Novartis Investigative Site

Marburg, 35039, Germany

Location

Novartis Investigative Site

München, 80336, Germany

Location

Novartis Investigative Site

München, 81675, Germany

Location

Novartis Investigative Site

Münster, 48145, Germany

Location

Novartis Investigative Site

Münster, 48149, Germany

Location

Novartis Investigative Site

Regensburg, 93042, Germany

Location

Novartis Investigative Site

Tübingen, 72076, Germany

Location

Novartis Investigative Site

Ulm, 89075, Germany

Location

MeSH Terms

Interventions

Ranibizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Study Director
Organization
Novartis Pharmaceuticals
Novartis.email@novartis.com
1-862-778-8300

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2012

First Posted

May 9, 2012

Study Start

December 11, 2012

Primary Completion

November 30, 2016

Study Completion

December 5, 2017

Last Updated

March 15, 2019

Results First Posted

March 15, 2019

Record last verified: 2018-11

Locations

DE(23)