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Proliferative Diabetic Retinopathy (PDR)Phase 2PRIDENCT01594281

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)

A Phase 2 study testing Ranibizumab 0.5 mg and Panretinal laser photocoagulation in people with Proliferative Diabetic Retinopathy (PDR), run by Novartis Pharmaceuticals at 23 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Proliferative Diabetic Retinopathy (PDR)
What is being tested?
Ranibizumab 0.5 mg and Panretinal laser photocoagulation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
107 participants
Where
23 sitesGermany
Study dates
11 Dec 2012to 5 Dec 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

23 sites in 1 country.

23 sites in 1 country

Germany23 sites

  • Novartis Investigative Site

    Aachen, 52074

  • Novartis Investigative Site

    Augsburg, 86156

  • Novartis Investigative Site

    Berlin, 12203

  • Novartis Investigative Site

    Cologne, 51109

  • Novartis Investigative Site

    Darmstadt, 64297

  • Novartis Investigative Site

    Düsseldorf, 40225

  • Novartis Investigative Site

    Essen, 45122

  • Novartis Investigative Site

    Freiburg im Breisgau, 79106

  • Novartis Investigative Site

    Glauchau, 08371

  • Novartis Investigative Site

    Göttingen, 37075

  • Novartis Investigative Site

    Hamburg, 20246

  • Novartis Investigative Site

    Hösbach, 63768

  • Novartis Investigative Site

    Karlsruhe, 76133

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Mainz, 55131

  • Novartis Investigative Site

    Marburg, 35039

  • Novartis Investigative Site

    München, 80336

  • Novartis Investigative Site

    München, 81675

  • Novartis Investigative Site

    Münster, 48145

  • Novartis Investigative Site

    Münster, 48149

  • Novartis Investigative Site

    Regensburg, 93042

  • Novartis Investigative Site

    Tübingen, 72076

  • Novartis Investigative Site

    Ulm, 89075

Other trials in Germany

About this study

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

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).

Read the 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.

Being tested
Ranibizumab 0.5 mg, Panretinal laser photocoagulation
Keywords
Panretinal photocoagulation, Ranibizumab

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ranibizumab 0.5 mgDrug

    Also called Lucentis®, RFB002

    Pre-filled syringe for intravitreal injection

  • Panretinal laser photocoagulationProcedure or surgery

    Also called PRP

    PRP treatment following DRS guidelines

Study groups in NCT01594281
Study groupRoleWhat they receive
Ranibizumab monoExperimentalInterventional 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)
Receives: Drug: Ranibizumab 0.5 mg
PRP monoActive comparatorInterventional 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
Receives: Procedure: Panretinal laser photocoagulation
Ranibizumab+PRPExperimentalInterventional 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
Receives: Drug: Ranibizumab 0.5 mg; Procedure: Panretinal laser photocoagulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, EOCS

Secondary outcomes (8)

  1. Change From Baseline in Area of Neovascularizations (NVs) at 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.

    Measured: Baseline, Month 3

  2. Best Corrected Visual Acuity (BCVA) (ETDRS Letters) at 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.

    Measured: EOCS

  3. Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at 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.

    Measured: Baseline, EOCS

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

    Measured: Baseline, EOCS

  5. Change From Baseline in Central Subfield Thickness at 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.

    Measured: Baseline, EOCS

  6. Change From Baseline in Foveal Center Point Retinal Thickness at 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.

    Measured: Baseline, EOCS

  7. Number of Ranibizumab Injections Until EOCS

    The total number of ranibizumab injections until EOCS was calculated. One eye (study eye) contributed to the analysis. No statistical analysis was conducted.

    Measured: Baseline to EOCS

  8. Number of PRP Laser Spots Until 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.

    Measured: Baseline to EOCS

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2012 (estimated)
  2. Study start11 Dec 2012
  3. Primary completion30 Nov 2016
  4. Study completion5 Dec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
107 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01594281
Sponsor's protocol ID
CRFB002DDE21
Other IDs
2011-005542-35
Acronym
PRIDE
Status last verified
Nov 2018
First submitted
3 May 2012
Last updated
15 Mar 2019
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ranibizumab 0.5 mg and Panretinal laser photocoagulation in people with Proliferative Diabetic Retinopathy (PDR), run by Novartis Pharmaceuticals at 23 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Area of Neovascularizations (NVs) at End of Core Study (EOCS) (time frame: Baseline, EOCS). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01594281.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019; AzTrials last refreshed its copy on 1 Nov 2026.

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