Trial record 6 of 309 for:
Panorama
Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR) (PANORAMA)
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| ClinicalTrials.gov Identifier: NCT02718326 |
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Recruitment Status :
Active, not recruiting
First Posted : March 24, 2016
Last Update Posted : May 22, 2018
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Sponsor:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
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Brief Summary:
The primary objective of the study is to assess the efficacy of intravitreal (IVT) aflibercept compared to sham treatment in the improvement of moderately severe to severe nonproliferative diabetic retinopathy (NPDR).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Nonproliferative Diabetic Retinopathy | Drug: Intravitreal aflibercept injection [IAI] Drug: Sham | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 402 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 3, Double-Masked, Randomized Study of the Efficacy and Safety of Intravitreal Aflibercept Injection in Patients With Moderately Severe to Severe Nonproliferative Diabetic Retinopathy |
| Actual Study Start Date : | March 29, 2016 |
| Estimated Primary Completion Date : | August 6, 2018 |
| Estimated Study Completion Date : | August 14, 2019 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Dosing regimen 1
In this arm, patients will receive IVT aflibercept dosing regimen 1
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Drug: Intravitreal aflibercept injection [IAI]
Other Names:
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Experimental: Dosing regimen 2
In this arm, patients will receive IVT aflibercept dosing regimen 2
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Drug: Intravitreal aflibercept injection [IAI]
Other Names:
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Sham Comparator: Dosing regimen 3
In this arm, patients will receive matching sham injections
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Drug: Sham |
Primary Outcome Measures :
- Proportion of participants who have improved by ≥2 steps from baseline on the Diabetic Retinopathy Severity Scale (DRSS) score at week 24 [ Time Frame: At week 24 ]
- Proportion of patients who have improved by ≥2 steps from baseline on the DRSS score at week 52 [ Time Frame: At week 52 ]
Secondary Outcome Measures :
- Proportion of participants developing a vision-threatening complication due to diabetic retinopathy through week 100 [ Time Frame: Baseline to week 100 ]
- Proportion of participants developing central-involved DME (CI-DME) through week 100 [ Time Frame: Baseline to week 100 ]
- Time to development of a vision-threatening complication through week 100 [ Time Frame: Baseline to week 100 ]
- Time to development of CI-DME through week 100 [ Time Frame: Baseline to week 100 ]
- Proportion of participants who receive panretinal photocoagulation (PRP) through week 100 [ Time Frame: Baseline to week 100 ]
- Area under the curve (AUC) for change in best corrected visual acuity (BCVA) from baseline at week 100 [ Time Frame: At week 100 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Men or women ≥18 years of age with type 1 or 2 diabetes mellitus who have moderately severe to severe NPDR (DRSS levels 47 or 53), confirmed by the central reading center, in whom PRP can be safely deferred for at least 6 months per the investigator
- BCVA ETDRS letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)
Key Exclusion Criteria:
- Presence of DME threatening the center of the macula in the study eye
- Evidence of retinal neovascularization on clinical examination or Fluorescein Angiography (FA)
- Any prior focal or grid laser photocoagulation or any prior PRP in the study eye
- Any prior systemic anti-VEGF treatment or IVT anti-VEGF treatment in the study eye
- Any prior intraocular steroid injection in the study eye
- Current anterior segment neovascularization (ASNV), vitreous hemorrhage, or tractional retinal detachment visible at the screening assessments in the study eye
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02718326
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Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
| Study Director: | Clinical Trial Management | Regeneron Pharmaceuticals |
| Responsible Party: | Regeneron Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02718326 History of Changes |
| Other Study ID Numbers: |
VGFTe-OD-1411 |
| First Posted: | March 24, 2016 Key Record Dates |
| Last Update Posted: | May 22, 2018 |
| Last Verified: | May 2018 |
Additional relevant MeSH terms:
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Retinal Diseases Diabetic Retinopathy Eye Diseases Diabetic Angiopathies Vascular Diseases |
Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |