Trial · NCT01594281
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)
NCT01594281, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2019-03-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. 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). Trials, record NCT01594281. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01594281
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
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)
- NCT number
- NCT01594281
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 107 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Proliferative Diabetic Retinopathy (PDR)
- Interventions
- Ranibizumab 0.5 mg, Panretinal laser photocoagulation
- First posted
- 2012-05-09
- Last updated
- 2019-03-15
- Other registries' IDs
- eudract:2011-005542-35
- Results first posted
- 2019-03-15
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Area of Neovascularizations (NVs) at End of Core Study (EOCS) | 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 | Change From Baseline in Area of Neovascularizations (NVs) at Month 3 | 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. |
| Secondary | Best Corrected Visual Acuity (BCVA) (ETDRS Letters) at EOCS | 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. |
| Secondary | Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | 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. |
| Secondary | Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS | 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. |
| Secondary | Change From Baseline in Central Subfield Thickness at EOCS | 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. |
| Secondary | Change From Baseline in Foveal Center Point Retinal Thickness at EOCS | 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. |
| Secondary | Number of Ranibizumab Injections Until EOCS | 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. |
| Secondary | Number of PRP Laser Spots Until EOCS | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Area of Neovascularizations (NVs) at End of Core Study (EOCS) | Baseline, EOCS | FAS; LOCF. Only patients with both values at baseline and any post-baseline value were included. | square millimeters | MEAN |
| SECONDARY | Change From Baseline in Area of Neovascularizations (NVs) at Month 3 | Baseline, Month 3 | FAS; LOCF. Only patients with both values at baseline and any post-baseline value were included. | square millimeters | MEAN |
| SECONDARY | Best Corrected Visual Acuity (BCVA) (ETDRS Letters) at EOCS | EOCS | FAS; LOCF | letters | MEAN |
| SECONDARY | Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | Baseline, EOCS | FAS; LOCF | percentage of participants | NUMBER |
| SECONDARY | Number of Patients With Change From Baseline in ETDRS Severity Grade of Diabetic Retinopathy (DR) at EOCS | Baseline, EOCS | FAS. Only patients with both values at baseline and any post-baseline value were included. | participants | NUMBER |
| SECONDARY | Change From Baseline in Central Subfield Thickness at EOCS | Baseline, EOCS | FAS; LOCF. Only patients with both values at baseline and any post-baseline value were included. | micrometer | MEAN |
| SECONDARY | Change From Baseline in Foveal Center Point Retinal Thickness at EOCS | Baseline, EOCS | FAS; LOCF. Only patients with both values at baseline and any post-baseline value were included. | micrometer | MEAN |
| SECONDARY | Number of Ranibizumab Injections Until EOCS | Baseline to EOCS | Safety Set. This outcome measure was pre-specified for the ranibizumab mono and ranibizumab+PRP arms only. | injections | MEAN |
| SECONDARY | Number of PRP Laser Spots Until EOCS | Baseline to EOCS | Safety Set. Only patients with at least 1 laser therapy until EOCS are included in the analysis. This outcome measure was pre-specified for the PRP and the ranibizumab+PRP arms only. | PRP laser spots | MEAN |
Source ClinicalTrials.gov
Results by group54
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Area of Neovascularizations (NVs) at End of Core Study (EOCS) | Ranibizumab Mono | -4.6 | Standard Deviation 11.3 | square millimeters | |
| Change From Baseline in Area of Neovascularizations (NVs) at End of Core Study (EOCS) | PRP Mono | -0.9 | Standard Deviation 3.9 | square millimeters | |
| Change From Baseline in Area of Neovascularizations (NVs) at End of Core Study (EOCS) | Ranibizumab+PRP | -1.7 | Standard Deviation 3.0 | square millimeters | |
| Change From Baseline in Area of Neovascularizations (NVs) at Month 3 | Ranibizumab Mono | -5.9 | Standard Deviation 12.7 | square millimeters | |
| Change From Baseline in Area of Neovascularizations (NVs) at Month 3 | PRP Mono | -0.7 | Standard Deviation 2.8 | square millimeters | |
| Change From Baseline in Area of Neovascularizations (NVs) at Month 3 | Ranibizumab+PRP | -2.7 | Standard Deviation 3.9 | square millimeters | |
| Best Corrected Visual Acuity (BCVA) (ETDRS Letters) at EOCS | Ranibizumab Mono | 84.4 | Standard Deviation 8.6 | letters | |
| Best Corrected Visual Acuity (BCVA) (ETDRS Letters) at EOCS | PRP Mono | 76.8 | Standard Deviation 17.0 | letters | |
| Best Corrected Visual Acuity (BCVA) (ETDRS Letters) at EOCS | Ranibizumab+PRP | 78.9 | Standard Deviation 12.2 | letters | |
| Percentage of Patients With Change From Baseline in BCVA (ETDRS Letters) at EOCS | Ranibizumab Mono | ≥15 letters gain from Baseline at EOCS | 0.0 | percentage of participants |
1 to 10 of 54Source ClinicalTrials.gov
See all 54 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Interventional Core Phase | STARTED | Ranibizumab Mono | 36 | |
| Interventional Core Phase | STARTED | PRP Mono | 36 | |
| Interventional Core Phase | STARTED | Ranibizumab+PRP | 36 | |
| Interventional Core Phase | Full Analysis Set (FAS) | Ranibizumab Mono | 35 | |
| Interventional Core Phase | Full Analysis Set (FAS) | PRP Mono | 35 | |
| Interventional Core Phase | Full Analysis Set (FAS) | Ranibizumab+PRP | 36 | |
| Interventional Core Phase | COMPLETED | Ranibizumab Mono | 29 | |
| Interventional Core Phase | COMPLETED | PRP Mono | 26 | |
| Interventional Core Phase | COMPLETED | Ranibizumab+PRP | 28 | |
| Interventional Core Phase | NOT COMPLETED | Ranibizumab Mono | 7 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events990
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | HYPOTHYROIDISM (Non-ocular) | Endocrine disorders | Ranibizumab Mono Until Month 12 | 0 | 35 | |
| other | HYPOTHYROIDISM (Non-ocular) | Endocrine disorders | PRP Mono Until Month 12 | 0 | 35 | |
| other | HYPOTHYROIDISM (Non-ocular) | Endocrine disorders | Ranibizumab+PRP Until Month 12 | 0 | 36 | |
| other | HYPOTHYROIDISM (Non-ocular) | Endocrine disorders | Ranibizumab Mono Month 12 to 24 | 0 | 28 | |
| other | HYPOTHYROIDISM (Non-ocular) | Endocrine disorders | PRP Mono Month 12 to 24 | 2 | 20 | |
| other | HYPOTHYROIDISM (Non-ocular) | Endocrine disorders | Ranibizumab+PRP Month 12 to 24 | 0 | 25 | |
| other | ABNORMAL SENSATION IN EYE (Right eye) | Eye disorders | Ranibizumab Mono Until Month 12 | 0 | 35 | |
| other | ABNORMAL SENSATION IN EYE (Right eye) | Eye disorders | PRP Mono Until Month 12 | 2 | 35 | |
| other | ABNORMAL SENSATION IN EYE (Right eye) | Eye disorders | Ranibizumab+PRP Until Month 12 | 0 | 36 | |
| other | ABNORMAL SENSATION IN EYE (Right eye) | Eye disorders | Ranibizumab Mono Month 12 to 24 | 0 | 28 |
1 to 10 of 990Source ClinicalTrials.gov
See all 990 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ranibizumab Mono Until Month 12 | 1 | 35 |
| Total, all-cause mortality | PRP Mono Until Month 12 | 1 | 35 |
| Total, all-cause mortality | Ranibizumab+PRP Until Month 12 | 2 | 36 |
| Total, all-cause mortality | Ranibizumab Mono Month 12 to 24 | 0 | 28 |
| Total, all-cause mortality | PRP Mono Month 12 to 24 | 0 | 20 |
| Total, all-cause mortality | Ranibizumab+PRP Month 12 to 24 | 0 | 25 |
| Total, other adverse events | Ranibizumab Mono Until Month 12 | 34 | 35 |
| Total, other adverse events | PRP Mono Until Month 12 | 29 | 35 |
| Total, other adverse events | Ranibizumab+PRP Until Month 12 | 34 | 36 |
| Total, other adverse events | Ranibizumab Mono Month 12 to 24 | 21 | 28 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01594281
GET https://conductscience.org/api/trials/v1/NCT01594281/results?page=2