Trial · NCT02718326
Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)
NCT02718326, Phase 3, Completed, Regeneron Pharmaceuticals; results first posted 2019-11-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR). Trials, record NCT02718326. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02718326
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)
- NCT number
- NCT02718326
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 402 participants, actual
- Lead sponsor
- Regeneron Pharmaceuticals
- Conditions
- Nonproliferative Diabetic Retinopathy
- Interventions
- Intravitreal aflibercept injection [IAI], Sham
- First posted
- 2016-03-24
- Last updated
- 2020-07-30
- Other registries' IDs
- eudract:2016-002639-14
- Results first posted
- 2019-11-21
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Improved by ≥2 Steps From Baseline in the Diabetic Retinopathy Disease Severity Scale (DRSS) Score at Week 24 in the Combined 2Q16 and 2Q8 Groups | At Week 24 | The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at week 24 from baseline. |
| Primary | Percentage of Participants With a ≥ 2-step Change at Week 52 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline | At Week 52 | The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached). Here, DRSS describes severity level 47 (moderately severe NPDR) and level 53 (severe NPDR) at week 52 from baseline. |
| Secondary | Percentage of Participants Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Week 52 | At Week 52 | Vision-threatening complications are defined as the composite outcome of proliferative diabetic retinopathy (PDR) (inclusive of participants who have vitreous hemorrhage or tractional retinal detachment believed to be due to PDR) and anterior segment neovascularization (ASNV) (participants with neovascularization of the iris \[at least 2 cumulative clock hours\], and/or definitive neovascularization of the iridocorneal angle). |
| Secondary | Percentage of Participants Who Developed Central Involved-Diabetic Macular Edema (CI-DME) at Week 52 | At Week 52 | The percentage of participants who developed CI-DME at week 52 were reported. |
| Secondary | Time to Development of Any Neovascular Vision Threatening Complication (PDR/ASNV) Through Week 52 | Baseline through week 52 (day 365) | Vision-threatening complication (VTC) is defined as the composite outcome of proliferative diabetic retinopathy (PDR) (inclusive of participants who have vitreous hemorrhage or tractional retinal detachment believed to be due to PDR) and anterior segment neovascularization (ASNV) (participants with neovascularization of the iris \[at least 2 cumulative clock hours\], and/or definitive neovascularization of the iridocorneal angle). Vision Threatening Complications include PDR/ASNV identified by investigators and Diabetic Retinopathy Scale Score (DRSS) \>61. |
| Secondary | Time to Development of Central Involved-Diabetic Macular Edema (CI-DME) Through Week 52 | Baseline through week 52 (day 365) | Time to develop Central Involved-Diabetic Macular Edema (CI-DME) through week 52 reported. |
| Secondary | Percentage of Participants Who Received Panretinal Photocoagulation (PRP), Inclusive of Participants Undergoing Vitrectomy With Endolaser, at Week 52 | At Week 52 | The percentage of participants who received panretinal photocoagulation (PRP), inclusive of participants undergoing vitrectomy with endolaser, at week 52 were reported. |
| Secondary | Area Under the Curve (AUC) for Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 52 | At week 52 | The area under the curve (AUC) is the area under the best corrected visual acuity (BCVA) versus time curve from baseline to week 52. Visual function of the study eye was assessed at a distance of 4 meters at every study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA) letter score. BCVA scale range is 0 (worst) to 100 (best). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Improved by ≥2 Steps From Baseline in the Diabetic Retinopathy Disease Severity Scale (DRSS) Score at Week 24 in the Combined 2Q16 and 2Q8 Groups | At Week 24 | FAS included all randomized participants who received any study treatment as assigned at baseline (as randomized). The missing data were imputed using last observation carried forward (LOCF) method. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With a ≥ 2-step Change at Week 52 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline | At Week 52 | FAS included all randomized participants who received any study treatment as assigned at baseline (as randomized). The missing data were imputed using LOCF method. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Week 52 | At Week 52 | FAS included all randomized participants who received any study treatment as assigned at baseline (as randomized). | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Developed Central Involved-Diabetic Macular Edema (CI-DME) at Week 52 | At Week 52 | FAS included all randomized participants who received any study treatment as assigned at baseline (as randomized). | Percentage of participants | NUMBER |
| SECONDARY | Time to Development of Any Neovascular Vision Threatening Complication (PDR/ASNV) Through Week 52 | Baseline through week 52 (day 365) | FAS included all randomized participants who received any study treatment as assigned at baseline (as randomized). Participants who did not have an event were censored at their last visit at or before the week 52 visit.~Here, the value NA = Not evaluable due to small number of VTC events. | Days | MEDIAN |
| SECONDARY | Time to Development of Central Involved-Diabetic Macular Edema (CI-DME) Through Week 52 | Baseline through week 52 (day 365) | FAS included all randomized participants who received any study treatment as assigned at baseline (as randomized). Participants who did not have an event were censored at their last visit, at or before the week 52 visit. Here, the value NA = Not evaluable due to small number of CI-DME events. | Days | MEDIAN |
| SECONDARY | Percentage of Participants Who Received Panretinal Photocoagulation (PRP), Inclusive of Participants Undergoing Vitrectomy With Endolaser, at Week 52 | At Week 52 | FAS included all randomized participants who received any study treatment as assigned at baseline (as randomized). | Percentage of participants | NUMBER |
| SECONDARY | Area Under the Curve (AUC) for Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 52 | At week 52 | AUC was calculated as a weighted average based on total AUC (using the trapezoidal rule) divided by total duration in days. FAS included all randomized participants who received any study treatment as assigned at baseline (as randomized). | scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Who Improved by ≥2 Steps From Baseline in the Diabetic Retinopathy Disease Severity Scale (DRSS) Score at Week 24 in the Combined 2Q16 and 2Q8 Groups | Sham Treatment | 6.0 | Percentage of participants | ||
| Percentage of Participants Who Improved by ≥2 Steps From Baseline in the Diabetic Retinopathy Disease Severity Scale (DRSS) Score at Week 24 in the Combined 2Q16 and 2Q8 Groups | Intravitreal Aflibercept Injection (IAI) 2Q16 | 61.5 | Percentage of participants | ||
| Percentage of Participants Who Improved by ≥2 Steps From Baseline in the Diabetic Retinopathy Disease Severity Scale (DRSS) Score at Week 24 in the Combined 2Q16 and 2Q8 Groups | Intravitreal Aflibercept Injection (IAI) 2Q8 | 55.2 | Percentage of participants | ||
| Percentage of Participants Who Improved by ≥2 Steps From Baseline in the Diabetic Retinopathy Disease Severity Scale (DRSS) Score at Week 24 in the Combined 2Q16 and 2Q8 Groups | IAI 2 mg Groups Combined (2Q16 & 2Q8) | 58.4 | Percentage of participants | ||
| Percentage of Participants With a ≥ 2-step Change at Week 52 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline | Sham Treatment | 15.0 | Percentage of participants | ||
| Percentage of Participants With a ≥ 2-step Change at Week 52 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline | Intravitreal Aflibercept Injection (IAI) 2Q16 | 65.2 | Percentage of participants | ||
| Percentage of Participants With a ≥ 2-step Change at Week 52 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline | Intravitreal Aflibercept Injection (IAI) 2Q8 | 79.9 | Percentage of participants | ||
| Percentage of Participants Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Week 52 | Sham Treatment | 20.3 | Percentage of participants | ||
| Percentage of Participants Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Week 52 | Intravitreal Aflibercept Injection (IAI) 2Q16 | 3.7 | Percentage of participants | ||
| Percentage of Participants Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Week 52 | Intravitreal Aflibercept Injection (IAI) 2Q8 | 3.0 | Percentage of participants |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Sham Treatment | 133 | 133 |
| Overall Study | STARTED | Intravitreal Aflibercept Injection (IAI) 2Q16 | 135 | 135 |
| Overall Study | STARTED | Intravitreal Aflibercept Injection (IAI) 2Q8 | 134 | 134 |
| Overall Study | Completed Week 52 | Sham Treatment | 109 | 109 |
| Overall Study | Completed Week 52 | Intravitreal Aflibercept Injection (IAI) 2Q16 | 122 | 122 |
| Overall Study | Completed Week 52 | Intravitreal Aflibercept Injection (IAI) 2Q8 | 124 | 124 |
| Overall Study | COMPLETED | Sham Treatment | 97 | 97 |
| Overall Study | COMPLETED | Intravitreal Aflibercept Injection (IAI) 2Q16 | 111 | 111 |
| Overall Study | COMPLETED | Intravitreal Aflibercept Injection (IAI) 2Q8 | 112 | 112 |
| Overall Study | NOT COMPLETED | Sham Treatment | 36 | 36 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events664
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 | Constipation | Gastrointestinal disorders | Sham Treatment | 3 | 133 | 3 |
| other | Constipation | Gastrointestinal disorders | Intravitreal Aflibercept Injection (IAI) 2Q16 | 5 | 135 | 5 |
| other | Constipation | Gastrointestinal disorders | Intravitreal Aflibercept Injection (IAI) 2Q8 | 7 | 134 | 7 |
| other | Constipation | Gastrointestinal disorders | IAI 2 mg Groups Combined (2Q16 & 2Q8) | 12 | 269 | 12 |
| other | Nausea | Gastrointestinal disorders | Sham Treatment | 8 | 133 | 9 |
| other | Nausea | Gastrointestinal disorders | Intravitreal Aflibercept Injection (IAI) 2Q16 | 5 | 135 | 5 |
| other | Nausea | Gastrointestinal disorders | Intravitreal Aflibercept Injection (IAI) 2Q8 | 6 | 134 | 14 |
| other | Nausea | Gastrointestinal disorders | IAI 2 mg Groups Combined (2Q16 & 2Q8) | 11 | 269 | 19 |
| other | Bronchitis | Infections and infestations | Sham Treatment | 7 | 133 | 7 |
| other | Bronchitis | Infections and infestations | Intravitreal Aflibercept Injection (IAI) 2Q16 | 9 | 135 | 10 |
1 to 10 of 664Source ClinicalTrials.gov
See all 664 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sham Treatment | 8 | 133 |
| Total, all-cause mortality | Intravitreal Aflibercept Injection (IAI) 2Q16 | 1 | 135 |
| Total, all-cause mortality | Intravitreal Aflibercept Injection (IAI) 2Q8 | 3 | 134 |
| Total, all-cause mortality | IAI 2 mg Groups Combined (2Q16 & 2Q8) | 4 | 269 |
| Total, other adverse events | Sham Treatment | 104 | 133 |
| Total, other adverse events | Intravitreal Aflibercept Injection (IAI) 2Q16 | 104 | 135 |
| Total, other adverse events | Intravitreal Aflibercept Injection (IAI) 2Q8 | 106 | 134 |
| Total, other adverse events | IAI 2 mg Groups Combined (2Q16 & 2Q8) | 210 | 269 |
| Total, serious adverse events | Sham Treatment | 38 | 133 |
| Total, serious adverse events | Intravitreal Aflibercept Injection (IAI) 2Q16 | 38 | 135 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34351414 | 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 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/NCT02718326
GET https://conductscience.org/api/trials/v1/NCT02718326/results?page=2