Nonproliferative Diabetic RetinopathyPhase 3PANORAMANCT02718326

Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)

A Phase 3 study testing Intravitreal aflibercept injection [IAI] in people with Nonproliferative Diabetic Retinopathy, run by Regeneron Pharmaceuticals at 89 sites in 6 countries.

Completed

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

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Nonproliferative Diabetic Retinopathy
What is being tested?: Intravitreal aflibercept injection [IAI]
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 402 participants
Where: 89 sitesin 6 countries
Study dates: 29 Mar 2016to 16 Jul 2019
Phase: Phase 3
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

Men or women ≥18 years of age with type 1 or 2 diabetes mellitus who have moderately severe to severe nonproliferative diabetic retinopathy (NPDR) [(diabetic retinopathy severity scale (DRSS) levels 47 or 53)], confirmed by the central reading center, in whom panretinal photocoagulation (PRP) can be safely deferred for at least 6 months per the investigator
Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)

Who cannot join

Presence of diabetic macular edema (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-vascular endothelial growth factor (VEGF) treatment or intravitreal (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
Note: Other inclusion/ exclusion criteria apply

Trial locations and contacts

89 sites in 6 countries.

Country

City, postcode or hospital

89 sites in 6 countries

United States71 sites

Regeneron Study Site
Abilene, Texas, 79606
Regeneron Study Site
Albuquerque, New Mexico, 87109
Regeneron Study Site
Altamonte Springs, Florida, 32701
Regeneron Study Site
Arcadia, California, 91007
Regeneron Study Site
Asheville, North Carolina, 28803
Regeneron Study Site 1
Austin, Texas, 78705
Regeneron Study Site 2
Austin, Texas, 78705
Regeneron Study Site
Baltimore, Maryland, 21204
Regeneron Study Siste
Baltimore, Maryland, 21209
Regeneron Study Site
Baltimore, Maryland, 21287
Regeneron Study Site
Beverly Hills, California, 90211
Regeneron Study Site
Bloomfield, New Jersey, 07003
Regeneron Study Site
Boston, Massachusetts, 02114
Regeneron Study Site
Burlington, Vermont, 05401
Regeneron Study Site
Charlotte, North Carolina, 28210
Regeneron Study Site
Chattanooga, Tennessee, 37421
Regeneron Study Site
Chicago, Illinois, 60612
Regeneron Study Site
Colorado Springs, Colorado, 80909
Regeneron Study Site
Columbus, Ohio, 43212
Regeneron Study Site
Dallas, Texas, 75231
Regeneron Study Site
Deerfield Beach, Florida, 33064
Regeneron Study Site
Encino, California, 91436
Regeneron Study Site
Fairfax, Virginia, 22031
Regeneron Study Site
Florence, South Carolina, 29501
Regeneron Study Site
Fort Myers, Florida, 33912
Regeneron Study Site
Fullerton, California, 92835
Regeneron Study Site
Germantown, Tennessee, 38138
Regeneron Study Site
Golden, Colorado, 80401
Regeneron Study Site
Hagerstown, Maryland, 21740
Regeneron Study Site
Harlingen, Texas, 78559
Regeneron Study Site
Henderson, Nevada, 89052
Regeneron Study Site
Houston, Texas, 77030
Regeneron Study Site
Indianapolis, Indiana, 46290
Regeneron Study Site
Kingston, Pennsylvania, 18704
Regeneron Study Site
La Jolla, California, 92093
Regeneron Study Site
Ladson, South Carolina, 29456
Regeneron Study Site
Lakeland, Florida, 33805
Regeneron Study Site
Largo, Florida, 33770
Regeneron Study Site
Lexington, Kentucky, 40509
Regeneron Study Ssites
Marietta, Georgia, 30060
Regeneron Study Site
Medford, Oregon, 97504
Regeneron Study Site
Melbourne, Florida, 32901
Regeneron Study Site
Miami, Florida, 33126
Regeneron Study Site
Miami, Florida, 33143
Regeneron Study Site
Morgantown, West Virginia, 26506
Regeneron Study Site
Mountain View, California, 94040
Regeneron Study Site
Nashville, Tennessee, 37203
Regeneron Study Site
Nashville, Tennessee, 37232
Regeneron Study Site
New Albany, Indiana, 47150
Regeneron Study Site
New London, Connecticut, 06320
Regeneron Study Site
Oak Forest, Illinois, 60452
Regeneron Study Site
Oakland, California, 94609
Regeneron Study Site
Oceanside, California, 92056
Regeneron Study Site
Oklahoma City, Oklahoma, 73104
Regeneron Study Site
Orlando, Florida, 32806
Regeneron Study Site
Philadelphia, Pennsylvania, 19107
Regeneron Study Site
Phoenix, Arizona, 85020
Regeneron Study Site
Plantation, Florida, 33324
Regeneron Study Site
Rapid City, South Dakota, 57701
Regeneron Study Site
Sacramento, California, 95841
Regeneron Study Site
Salt Lake City, Utah, 84132
Regeneron Study Site
San Antonio, Texas, 78240
Regeneron Study Site
Spokane, Washington, 99204
Regeneron Study Site
Tallahassee, Florida, 32308
Regeneron Study Site
Tampa, Florida, 33612
Regeneron Study Site
The Woodlands, Texas, 77384
Regeneron study Site
Tucker, Georgia, 30084
Regeneron Study Site
Tucson, Arizona, 85704
Regeneron Study Site
West Columbia, South Carolina, 29169
Regeneron Study Site
Willow Park, Texas, 76087
Regeneron Study Site
Winter Haven, Florida, 33880

Other trials in United States

Japan6 sites

Regeneron Study Site
Amagasaki, Hyōgo, 660-8550
Regeneron Study Site
Asahikawa, Hokkaido, 078-8510
Regeneron Study Site
Chiyoda City, Tokyo, 101-8309
Regeneron Study Site
Kagoshima, 890-8520
Regeneron Study Site
Matsumoto, Nagano, 390-8621
Regeneron Study Site
Nagasaki, 852-8501

Other trials in Japan

Hungary5 sites

Regeneron Study Site
Budapest, Pest County, 1062
Regeneron Study Site
Budapest, Pest County, 1106
Regeneron Study Site
Debrecen, Hajdú-Bihar, 4032
Regeneron Study Site
Szeged, Csongrád megye, 6720
Regeneron Study Site
Zalaegerszeg, Zala County, 8900

Other trials in Hungary

Germany3 sites

Regeneron Study Site
Leipzig, Saxony, 04103
Regeneron Study Site
Marburg, Hesse, 35043
Regeneron Study Site
Münster, North Rhine-Westphalia, 48145

Other trials in Germany

Puerto Rico2 sites

Regeneron Study Site
Arecibo, 00613
Regeneron Study Site
San Juan, 00907

Other trials in Puerto Rico

United Kingdom2 sites

Regeneron Study Site
Camberley, Surrey, GU16 7UJ
Regeneron Study Site
London, EC1V 2PD

Other trials in United Kingdom

About this study

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

The secondary objectives of the study are:

To characterize the safety of IVT aflibercept in patients with moderately severe to severe NPDR
To determine if IVT aflibercept will prevent the worsening of diabetic retinopathy and reduce the incidence of DME
To determine the anatomic effects of IVT aflibercept in patients with moderately severe to severe NPDR

Conditions: Nonproliferative Diabetic Retinopathy
Being tested: Intravitreal aflibercept injection [IAI], Sham

What participants receive

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

Intravitreal aflibercept injection [IAI]Drug
Also called EYLEA® (aflibercept) Injection, BAY86-5321
ShamDrug

Study groups in NCT02718326
Study group	Role	What they receive
Dosing regimen 1	Experimental	Participants will receive IVT aflibercept dosing regimen 1 Receives: Drug: Intravitreal aflibercept injection [IAI]
Dosing regimen 2	Experimental	Participants will receive IVT aflibercept dosing regimen 2 Receives: Drug: Intravitreal aflibercept injection [IAI]
Dosing regimen 3	Sham comparator	Participants will receive matching sham injections Receives: Drug: Sham

What is being measured

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

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
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.
Measured: At Week 24
Percentage of Participants With a ≥ 2-step Change at Week 52 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline
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.
Measured: At Week 52

Secondary outcomes (6)

Percentage of Participants Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy 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).
Measured: At Week 52
Percentage of Participants Who Developed Central Involved-Diabetic Macular Edema (CI-DME) at Week 52
The percentage of participants who developed CI-DME at week 52 were reported.
Measured: At Week 52
Time to Development of Any Neovascular Vision Threatening Complication (PDR/ASNV) Through Week 52
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.
Measured: Baseline through week 52 (day 365)
Time to Development of Central Involved-Diabetic Macular Edema (CI-DME) Through Week 52
Time to develop Central Involved-Diabetic Macular Edema (CI-DME) through week 52 reported.
Measured: Baseline through week 52 (day 365)
Percentage of Participants Who Received Panretinal Photocoagulation (PRP), Inclusive of Participants Undergoing Vitrectomy With Endolaser, at Week 52
The percentage of participants who received panretinal photocoagulation (PRP), inclusive of participants undergoing vitrectomy with endolaser, at week 52 were reported.
Measured: At Week 52
Area Under the Curve (AUC) for Change From Baseline in Best Corrected Visual Acuity (BCVA) 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).
Measured: At week 52

Timeline

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

29 Mar 201616 Jul 2019

First posted24 Mar 2016 (estimated)
Study start29 Mar 2016
Primary completion6 Aug 2018
Study completion16 Jul 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Nonproliferative Diabetic RetinopathyStudies of the same condition, open and under way.
More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 402 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02718326
Sponsor's protocol ID: VGFTe-OD-1411
Other IDs: 2016-002639-14, 2016
Acronym: PANORAMA
Status last verified: Jul 2020
First submitted: 20 Mar 2016
Last updated: 30 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

Brown DM, Wykoff CC, Boyer D, Heier JS, Clark WL, Emanuelli A, Higgins PM, Singer M, Weinreich DM, Yancopoulos GD, Berliner AJ, Chu K, Reed K, Cheng Y, Vitti R. Evaluation of Intravitreal Aflibercept for the Treatment of Severe Nonproliferative Diabetic Retinopathy: Results From the PANORAMA Randomized Clinical Trial. JAMA Ophthalmol. 2021 Sep 1;139(9):946-955. doi: 10.1001/jamaophthalmol.2021.2809.
PubMed 34351414

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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RecruitingPhase 1
A Study Intravitreal THN391 in Diabetic Macular Oedema Secondary to Non-Proliferative Diabetic Retinopathy.
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All Nonproliferative Diabetic Retinopathy trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02718326
Acronym / sponsor ID: PANORAMA / VGFTe-OD-1411
Conditions: Nonproliferative Diabetic Retinopathy
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 402 participants (actual)
Lead sponsor: Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 29 Mar 2016 (actual)
Primary completion: 6 Aug 2018 (actual)
Study completion: 16 Jul 2019 (actual)
First posted: 24 Mar 2016 (estimated)
Results: Posted 21 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The secondary objectives of the study are:

To characterize the safety of IVT aflibercept in patients with moderately severe to severe NPDR
To determine if IVT aflibercept will prevent the worsening of diabetic retinopathy and reduce the incidence of DME
To determine the anatomic effects of IVT aflibercept in patients with moderately severe to severe NPDR

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Dosing regimen 1	Experimental	Drug: Intravitreal aflibercept injection [IAI]Participants will receive IVT aflibercept dosing regimen 1
Dosing regimen 2	Experimental	Drug: Intravitreal aflibercept injection [IAI]Participants will receive IVT aflibercept dosing regimen 2
Dosing regimen 3	Sham comparator	Drug: ShamParticipants will receive matching sham injections

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Men or women ≥18 years of age with type 1 or 2 diabetes mellitus who have moderately severe to severe nonproliferative diabetic retinopathy (NPDR) [(diabetic retinopathy severity scale (DRSS) levels 47 or 53)], confirmed by the central reading center, in whom panretinal photocoagulation (PRP) can be safely deferred for at least 6 months per the investigator
Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)

Key exclusion criteria (7 listed)

Presence of diabetic macular edema (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-vascular endothelial growth factor (VEGF) treatment or intravitreal (IVT) anti-VEGF treatment in the study eye
Any prior intraocular steroid injection in the study eye

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Intravitreal aflibercept injection [IAI]Also: EYLEA® (aflibercept) Injection, BAY86-5321	Drug	Dosing regimen 1, Dosing regimen 2
Sham	Drug	Dosing regimen 3

Primary outcome

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
Time frame: 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.
Percentage of Participants With a ≥ 2-step Change at Week 52 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline
Time frame: 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.

6 secondary outcomes

Percentage of Participants Who Developed a Vision-Threatening Complication Due to Diabetic Retinopathy at Week 52
Time frame: At Week 52
Percentage of Participants Who Developed Central Involved-Diabetic Macular Edema (CI-DME) at Week 52
Time frame: At Week 52
Time to Development of Any Neovascular Vision Threatening Complication (PDR/ASNV) Through Week 52
Time frame: Baseline through week 52 (day 365)
Time to Development of Central Involved-Diabetic Macular Edema (CI-DME) Through Week 52
Time frame: Baseline through week 52 (day 365)
Percentage of Participants Who Received Panretinal Photocoagulation (PRP), Inclusive of Participants Undergoing Vitrectomy With Endolaser, at Week 52
Time frame: At Week 52
Area Under the Curve (AUC) for Change From Baseline in Best Corrected Visual Acuity (BCVA) at Week 52
Time frame: At week 52

Results and safety

Results posted to the registry on 21 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sham Treatment	133	97
Intravitreal Aflibercept Injection (IAI) 2Q16	135	111
Intravitreal Aflibercept Injection (IAI) 2Q8	134	112

Primary outcome: 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

Time frame: At Week 24. Number. Unit: Percentage of participants

Measure	Sham Treatment n = 133	Intravitreal Aflibercept Injection (IAI) 2Q16 n = 135	Intravitreal Aflibercept Injection (IAI) 2Q8 n = 134	IAI 2 mg Groups Combined (2Q16 & 2Q8) n = 269
Value	6.0	61.5	55.2	58.4

Sham Treatment vs IAI 2 mg Groups Combined (2Q16 & 2Q8): percentage difference: 52.3 (95% CI 45.2 to 59.5), p <0.0001, Cochran-Mantel-Haenszel

Population analysed: 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.

Primary outcome: Percentage of Participants With a ≥ 2-step Change at Week 52 in Diabetic Retinopathy Severity Scale (DRSS) From Baseline

Time frame: At Week 52. Number. Unit: Percentage of participants

Measure	Sham Treatment n = 133	Intravitreal Aflibercept Injection (IAI) 2Q16 n = 135	Intravitreal Aflibercept Injection (IAI) 2Q8 n = 134
Value	15.0	65.2	79.9

Sham Treatment vs Intravitreal Aflibercept Injection (IAI) 2Q16: percentage difference: 50.1 (95% CI 40.1 to 60.1), p <0.0001, Cochran-Mantel-Haenszel
Sham Treatment vs Intravitreal Aflibercept Injection (IAI) 2Q8: percentage difference: 64.8 (95% CI 55.8 to 73.9), p < 0.0001, Cochran-Mantel-Haenszel

Population analysed: FAS included all randomized participants who received any study treatment as assigned at baseline (as randomized). The missing data were imputed using LOCF method.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: All Adverse Events (AEs) were collected from signature of the informed consent form up to week 100 regardless of seriousness or relationship to investigational product. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Sham Treatment	38 of 133 (28.6%)	104 of 133 (78.2%)	8 of 133
Intravitreal Aflibercept Injection (IAI) 2Q16	38 of 135 (28.1%)	104 of 135 (77%)	1 of 135
Intravitreal Aflibercept Injection (IAI) 2Q8	47 of 134 (35.1%)	106 of 134 (79.1%)	3 of 134
IAI 2 mg Groups Combined (2Q16 & 2Q8)	85 of 269 (31.6%)	210 of 269 (78.1%)	4 of 269

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34351414Brown DM, Wykoff CC, Boyer D, Heier JS, Clark WL, Emanuelli A, Higgins PM, Singer M, Weinreich DM, Yancopoulos GD, Berliner AJ, Chu K, Reed K, Cheng Y, Vitti R. Evaluation of Intravitreal Aflibercept for the Treatment of Severe Nonproliferative Diabetic Retinopathy: Results From the PANORAMA Randomized Clinical Trial. JAMA Ophthalmol. 2021 Sep 1;139(9):946-955. doi: 10.1001/jamaophthalmol.2021.2809.

Related trials for Nonproliferative Diabetic Retinopathy

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trial Management study director

Regeneron Pharmaceuticals

89 sites in 6 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Intravitreal aflibercept injection [IAI] in people with Nonproliferative Diabetic Retinopathy, run by Regeneron Pharmaceuticals at 89 sites in 6 countries.

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 2 inclusion and 7 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 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, Japan, Hungary, Germany, Puerto Rico and 1 more country. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 21 Nov 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?

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 (time frame: At Week 24). The study lists 2 primary outcomes in all. 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 NCT02718326, which also lists 1 linked publication.

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 30 Jul 2020.