Trial · NCT04278417
Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy
NCT04278417, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2024-08-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy. Trials, record NCT04278417. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04278417
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Efficacy and Safety of Brolucizumab Versus Panretinal Photocoagulation Laser in Patients With Proliferative Diabetic Retinopathy
- NCT number
- NCT04278417
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 689 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Proliferative Diabetic Retinopathy
- Interventions
- Brolucizumab 6 mg, Panretinal photocoagulation laser
- First posted
- 2020-02-20
- Last updated
- 2025-10-16
- Results first posted
- 2024-08-20
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 54 for the Study Eye | Baseline, Week 54 | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of \>= 34 ETDRS letters (Snellen equivalent 20/200) at Screening / Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values. |
| Secondary | Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 54 for the Study Eye | Week 54 | Proliferative diabetic retinopathy (PDR) is derived from the diabetic retinopathy severity scale (DRSS) as assessed by the central reading center (CRC) using 7-field color fundus photography image. The DRSS on the original score with scores varying from 10 (DR absent) to 85 (very advanced PDR) were then converted into a 12-level scale (Range is from 1 - diabetic retinopathy (DR) absent, to 12- very advanced PDR). (A lower score represents a better outcome.) The event of "No PDR" is then defined as DRSS (12-level scale) \< 7. |
| Secondary | Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 96 for the Study Eye | Week 96 | Proliferative diabetic retinopathy (PDR) is derived from the diabetic retinopathy severity scale (DRSS) as assessed by the central reading center (CRC) using 7-field color fundus photography image. The DRSS on the original score with scores varying from 10 (DR absent) to 85 (very advanced PDR) were then converted into a 12-level scale (Range is from 1 - diabetic retinopathy (DR) absent, to 12- very advanced PDR). (A lower score represents a better outcome.) The event of "No PDR" is then defined as DRSS (12-level scale) \< 7. |
| Secondary | Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 54 for the Study Eye | Up to Week 54 | Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. PRP = Panretinal photocoagulation laser |
| Secondary | Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 96 for the Study Eye | Up to Week 96 | Assessed by Spectral domain optical coherence tomography (SD-OCT) from the central reading center. PRP = Panretinal photocoagulation laser |
| Secondary | Area Under the Curve in Change From Baseline in BCVA up to Week 54 and up to Week 96 - for the Study Eye | Baseline, up to Week 54 and up to Week 96 | BCVA was assessed using Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing charts. Visual function of the study eye was assessed using the ETDRS protocol. Participants with a BCVA ETDRS letter score of \>= 34 ETDRS letters (Snellen equivalent 20/200) at Screening / Baseline in the study eye were included. Min and max possible scores are 0-100 respectively. A higher score represents better functioning. Last observation carried forward (LOCF) was used for the imputation of missing values. The AUC in change from Baseline in BCVA up to Week 54 (or Week 96) is referred to as the averaged change from Baseline in BCVA at each visit up to 54 (or Week 96), which was calculated as (BCVA at Week 6 + BCVA at Week 12 + ... + BCVA at Week 54 (or Week 96)) / number of visits with valid BCVA data from Week 6 to Week 54 (or Week 96) - BCVA at Baseline. |
| Secondary | Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥2 Steps Improvement From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96 | Baseline, Week 54 and Week 96 | Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the ≥2-step and ≥3-step change from baseline for each post-baseline assessment". A lower score represents better functioning. |
| Secondary | Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥2 Steps Worsening From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96 | Baseline, Week 54 and Week 96 | Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the ≥2-step and ≥3-step change from baseline for each post-baseline assessment". A lower score represents better functioning. |
| Secondary | Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥3 Steps Improvement From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96 | Baseline, Week 54 and Week 96 | Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the ≥2-step and ≥3-step change from baseline for each post-baseline assessment". A lower score represents better functioning. |
| Secondary | Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥3 Steps Worsening From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96 | Baseline, Week 54 and Week 96 | Severity of Diabetic retinopathy was evaluated using the ETDRS DRSS score assessed by the Central Reading Center based on color fundus photography images in the study eye. When the ETDRS-DR severities were evaluable, they were categorized on the original scale with scores varying from 10 (DR absent) to 85 (very advanced PDR). All DRSS values were then converted into a 12-level scale, allowing the derivation of the ≥2-step and ≥3-step change from baseline for each post-baseline assessment". A lower score represents better functioning. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes14
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 Best-corrected Visual Acuity (BCVA) at Week 54 for the Study Eye | Baseline, Week 54 | Full Analysis Set- Last Observation Carried Forward (FAS - LOCF), for patients with a valid measurement with no protocol deviations with impact. | Letters Read | LEAST_SQUARES_MEAN |
| SECONDARY | Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 54 for the Study Eye | Week 54 | Full Analysis Set- Last Observation Carried Forward (FAS - LOCF), for patients with a valid measurement with no protocol deviations with impact. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 96 for the Study Eye | Week 96 | Full Analysis Set- Last Observation Carried Forward (FAS - LOCF), for patients with a valid measurement with no protocol deviations with impact. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 54 for the Study Eye | Up to Week 54 | Full Analysis Set (FAS), for patients with a valid measurement with no protocol deviations with impact. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 96 for the Study Eye | Up to Week 96 | Full Analysis Set (FAS), for patients with a valid measurement with no protocol deviations with impact. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Area Under the Curve in Change From Baseline in BCVA up to Week 54 and up to Week 96 - for the Study Eye | Baseline, up to Week 54 and up to Week 96 | Full Analysis Set- Last Observation Carried Forward (FAS - LOCF), for patients with a valid measurement with no protocol deviations with impact. | Letters read | LEAST_SQUARES_MEAN |
| SECONDARY | Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥2 Steps Improvement From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96 | Baseline, Week 54 and Week 96 | Full Analysis Set- Last Observation Carried Forward (FAS - LOCF), for patients with a valid measurement with no protocol deviations with impact. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥2 Steps Worsening From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96 | Baseline, Week 54 and Week 96 | Full Analysis Set- Observed, for patients with a valid measurement with no protocol deviations with impact. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥3 Steps Improvement From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96 | Baseline, Week 54 and Week 96 | Full Analysis Set- Last Observation Carried Forward (FAS - LOCF), for patients with a valid measurement with no protocol deviations with impact. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Diabetic Retinopathy Severity Scale (DRSS): Number and Percentage of Subjects With ≥3 Steps Worsening From Baseline in Early Treatment Diabetic Retinopathy Study (ETDRS) DRSS Score at Week 54 and Week 96 | Baseline, Week 54 and Week 96 | Full Analysis Set-Observed, for patients with a valid measurement with no protocol deviations with impact. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group114
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 Best-corrected Visual Acuity (BCVA) at Week 54 for the Study Eye | Brolucizumab 6 mg | 0.2 | Standard Error 0.72 | Letters Read | |
| Change From Baseline in Best-corrected Visual Acuity (BCVA) at Week 54 for the Study Eye | Panretinal Photocoagulation Laser Arm | -4.2 | Standard Error 0.73 | Letters Read | |
| Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 54 for the Study Eye | Brolucizumab 6 mg | 187 | Participants | ||
| Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 54 for the Study Eye | Panretinal Photocoagulation Laser Arm | 65 | Participants | ||
| Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 96 for the Study Eye | Brolucizumab 6 mg | 188 | Participants | ||
| Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 96 for the Study Eye | Panretinal Photocoagulation Laser Arm | 86 | Participants | ||
| Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 54 for the Study Eye | Brolucizumab 6 mg | 108 | Participants | ||
| Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 54 for the Study Eye | Panretinal Photocoagulation Laser Arm | 248 | Participants | ||
| Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 96 for the Study Eye | Brolucizumab 6 mg | 126 | Participants | ||
| Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 96 for the Study Eye | Panretinal Photocoagulation Laser Arm | 262 | Participants |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Brolucizumab 6 mg | 347 | |
| Overall Study | STARTED | Panretinal Photocoagulation Laser Arm | 342 | |
| Overall Study | COMPLETED | Brolucizumab 6 mg | 301 | |
| Overall Study | COMPLETED | Panretinal Photocoagulation Laser Arm | 287 | |
| Overall Study | NOT COMPLETED | Brolucizumab 6 mg | 46 | |
| Overall Study | NOT COMPLETED | Panretinal Photocoagulation Laser Arm | 55 |
Source ClinicalTrials.gov
Adverse events657
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 | Anaemia | Blood and lymphatic system disorders | Brolucizumab 6mg | 15 | 347 | |
| other | Anaemia | Blood and lymphatic system disorders | Panretinal Photocoagulation Laser Arm | 16 | 342 | |
| other | Anaemia | Blood and lymphatic system disorders | Overall | 31 | 689 | |
| other | Cataract - Fellow eye | Eye disorders | Brolucizumab 6mg | 22 | 347 | |
| other | Cataract - Fellow eye | Eye disorders | Panretinal Photocoagulation Laser Arm | 28 | 342 | |
| other | Cataract - Fellow eye | Eye disorders | Overall | 50 | 689 | |
| other | Cataract - Study eye | Eye disorders | Brolucizumab 6mg | 26 | 347 | |
| other | Cataract - Study eye | Eye disorders | Panretinal Photocoagulation Laser Arm | 29 | 342 | |
| other | Cataract - Study eye | Eye disorders | Overall | 55 | 689 | |
| other | Conjunctival haemorrhage - Study eye | Eye disorders | Brolucizumab 6mg | 10 | 347 |
1 to 10 of 657Source ClinicalTrials.gov
See all 657 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Brolucizumab 6mg | 8 | 347 |
| Total, all-cause mortality | Panretinal Photocoagulation Laser Arm | 9 | 342 |
| Total, all-cause mortality | Overall | 17 | 689 |
| Total, other adverse events | Brolucizumab 6mg | 241 | 347 |
| Total, other adverse events | Panretinal Photocoagulation Laser Arm | 254 | 342 |
| Total, other adverse events | Overall | 495 | 689 |
| Total, serious adverse events | Brolucizumab 6mg | 96 | 347 |
| Total, serious adverse events | Panretinal Photocoagulation Laser Arm | 105 | 342 |
| Total, serious adverse events | Overall | 201 | 689 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42024409 | DERIVED |
Source PubMed
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Brolucizumab 6 mg vs Panretinal Photocoagulation Laser Arm: Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 54 for the Study Eye | Trial comparisons |
| Brolucizumab 6 mg vs Panretinal Photocoagulation Laser Arm: Number and Percentage of Subjects With Center-involved Diabetic Macular Edema (CI- DME) up to Week 96 for the Study Eye | Trial comparisons |
| Brolucizumab 6 mg vs Panretinal Photocoagulation Laser Arm: Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 96 for the Study Eye | Trial comparisons |
| Brolucizumab 6 mg vs Panretinal Photocoagulation Laser Arm: Number and Percentage of Subjects With no Proliferative Diabetic Retinopathy (PDR) at Week 54 for the Study Eye | Trial comparisons |
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.
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GET https://conductscience.org/api/trials/v1/NCT04278417/results?page=2