Diabetic Retinopathy

Ophthalmology
24
Pipeline Programs
13
Companies
24
Clinical Trials
2 recruiting
6
Approved Products

Pipeline by Development Stage

Preclinical
Phase 1
Phase 1/2
Phase 2
Phase 2/3
Phase 3
On Market
0
1
2
8
0
5
8
Early DiscoveryClinical DevelopmentMarket

Drug Modality Breakdown

Monoclonal Antibody
250%
Peptide
250%
+ 20 programs with unclassified modality

On Market (6)

Approved therapies currently available

U
ANTARA (MICRONIZED)Approved
fenofibrate
Unknown Company
Peroxisome Proliferator Receptor alpha Agonist [EPC]oral2004
Regeneron
EYLEAApproved
aflibercept
Regeneron
Vascular Endothelial Growth Factor Inhibitor [EPC]injection2011
Regeneron
EYLEA HDApproved
aflibercept
Regeneron
Vascular Endothelial Growth Factor Inhibitor [EPC]injection2023
U
FENOFIBRATEApproved
fenofibrate
Unknown Company
Peroxisome Proliferator Receptor alpha Agonist [EPC]oral2024
U
FENOFIBRATE (MICRONIZED)Approved
fenofibrate
Unknown Company
Peroxisome Proliferator Receptor alpha Agonist [EPC]oral2013
U
TRIGLIDEApproved
fenofibrate
Unknown Company
oral2005

Competitive Landscape

12 companies ranked by most advanced pipeline stage

Regeneron
RegeneronTARRYTOWN, NY
5 programs
1
1
2
Aflibercept InjectionPhase 41 trial
afliberceptPhase 41 trial
Prompt ShamPhase 31 trial
Aflibercept InjectionPhase 21 trial
AfliberceptN/A
Active Trials
NCT03531294Completed40Est. Apr 2021
NCT02634333Completed399Est. May 2022
NCT04708145Completed41Est. Jul 2024
+1 more trials
Novartis
NovartisBASEL, Switzerland
3 programs
2
Octreotide acetate in microspheresPhase 3Peptide1 trial
Octreotide acetate in microspheresPhase 3Peptide1 trial
Studied cohortN/A1 trial
Active Trials
NCT02232503Completed4,011Est. Nov 2015
NCT00248131Terminated260Est. Jul 2006
NCT00248157Terminated105Est. May 2006
Alcon
AlconFORT WORTH, TX
2 programs
1
1
Nepafenac ophthalmic suspension, 0.1%Phase 31 trial
Anecortave Acetate Sterile SuspensionPhase 11 trial
Active Trials
NCT00211406Terminated
NCT00939276Terminated175Est. Aug 2011
Roche
RocheSTAVANGER NORWAY, Norway
1 program
1
FenofibratePhase 31 trial
Active Trials
NCT04661358Recruiting560Est. Dec 2029
Boehringer Ingelheim
Boehringer IngelheimINGELHEIM, Germany
5 programs
2
2
BI 1467335Phase 21 trial
BI 764524Phase 21 trial
BI 764524Phase 1/21 trial
BI 765128Phase 1/21 trial
Retinal Ischemia Characterization in Diabetes - "RICHARD"N/A1 trial
Active Trials
NCT05112445Active Not Recruiting60Est. Feb 2026
NCT04424290Completed45Est. Apr 2023
NCT04919499Completed46Est. Aug 2023
+2 more trials
Genentech
GenentechCA - Oceanside
2 programs
2
RanibizumabPhase 2Monoclonal Antibody1 trial
RanibizumabPhase 2Monoclonal Antibody1 trial
Active Trials
NCT01476449Completed20Est. Sep 2016
NCT00387582Completed49Est. Feb 2009
Pfizer
PfizerNEW YORK, NY
1 program
1
Laser TreatmentPhase 21 trial
Active Trials
NCT00701181Terminated184Est. Jan 2011
Bayer
BayerLEVERKUSEN, Germany
1 program
1
RuncaciguatPhase 22 trials
Active Trials
NCT04820621Terminated5Est. Jul 2021
NCT04722991Completed109Est. Apr 2024
Oxurion
OxurionBelgium - Leuven
1 program
1
ocriplasmin 0.0625mgPhase 21 trial
Active Trials
NCT02681809TerminatedEst. Nov 2019
Thea Pharma
Thea PharmaMA - Waltham
1 program
NutrofN/A1 trial
Active Trials
NCT04499820CompletedEst. Apr 2025
PulseMedica
PulseMedicaAB - Edmonton
1 program
OSNAT 800 ION/A1 trial
Active Trials
NCT05608265Completed60Est. Mar 2023
NV
Notal VisionVA - Manassas
1 program
Single In-Clinic Encounter With the Notal Vision Home OCT by DME PatientsN/A1 trial
Active Trials
NCT05417152CompletedEst. Mar 2023

Trial Timeline

Clinical trial activity over time

2021
2022
2023
2024
2025
2026
2027
2028
2029
RegeneronAflibercept Injection
Regeneronaflibercept
RocheFenofibrate
RegeneronPrompt Sham
AlconNepafenac ophthalmic suspension, 0.1%
NovartisOctreotide acetate in microspheres
NovartisOctreotide acetate in microspheres
Boehringer IngelheimBI 764524
BayerRuncaciguat
RegeneronAflibercept Injection
Boehringer IngelheimBI 1467335
Oxurionocriplasmin 0.0625mg
GenentechRanibizumab
PfizerLaser Treatment
GenentechRanibizumab

Showing 15 of 23 trials with date data

Clinical Trials (24)

Total enrollment: 6,446 patients across 24 trials

NCT04708145RegeneronAflibercept Injection

Long-Term Efficacy and Safety of Intravitreal Aflibercept Injections for the Treatment of Diabetic Retinopathy for Subjects Who Completed the 2-Year PANORAMA Trial

Start: Jun 2021Est. completion: Jul 202441 patients
Phase 4Completed
NCT02559180Regeneronaflibercept

Treatment of Diabetic Macular Edema With Aflibercept in Subjects Previously Treated With Ranibizumab or Bevacizumab

Start: Oct 2015Est. completion: Dec 202020 patients
Phase 4Completed
NCT04661358RocheFenofibrate

Fenofibrate for Prevention of DR Worsening

Start: Mar 2021Est. completion: Dec 2029560 patients
Phase 3Recruiting
NCT02634333RegeneronPrompt Sham

Anti-VEGF Treatment for Prevention of PDR/DME

Start: Jan 2016Est. completion: May 2022399 patients
Phase 3Completed
NCT00939276AlconNepafenac ophthalmic suspension, 0.1%

Macular Edema Incidence/Severity Reduction With Nevanac

Start: Aug 2009Est. completion: Aug 2011175 patients
Phase 3Terminated
NCT00248131NovartisOctreotide acetate in microspheres

Extension Study of Long-term Safety and Tolerability of Octreotide Acetate in Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy or Low Risk Proliferative Diabetic Retinopathy

Start: Nov 2005Est. completion: Jul 2006260 patients
Phase 3Terminated
NCT00248157NovartisOctreotide acetate in microspheres

Extension Study of the Long-term Safety and Tolerability of Octreotide Acetate in Patients With Moderately Severe or Severe Non-proliferative Diabetic Retinopathy or Low Risk Proliferative Diabetic Retinopathy

Start: Nov 2005Est. completion: May 2006105 patients
Phase 3Terminated
NCT06321302Boehringer IngelheimBI 764524

A Study to Test Whether BI 764524 Helps People With an Eye Condition Called Diabetic Retinopathy

Start: May 2024Est. completion: Sep 2027178 patients
Phase 2Recruiting
NCT04722991BayerRuncaciguat

Non-proliferative Diabetic Retinopathy Treated With Runcaciguat

Start: Mar 2021Est. completion: Apr 2024109 patients
Phase 2Completed
NCT03531294RegeneronAflibercept Injection

Intravitreal Aflibercept as Indicated by Real-Time Objective Imaging to Achieve Diabetic Retinopathy Improvement

Start: May 2018Est. completion: Apr 202140 patients
Phase 2Completed
NCT03238963Boehringer IngelheimBI 1467335

A Study That Tests BI 1467335 in Patients With Diabetic Eye Disease (Diabetic Retinopathy). It Looks at the Way BI 1467335 is Taken up, the Effects it Has, and How Well it is Tolerated.

Start: Sep 2017Est. completion: May 202079 patients
Phase 2Completed
NCT02681809Oxurionocriplasmin 0.0625mg

A Study to Evaluate the Efficacy and Safety of Ocriplasmin in Inducing Total PVD in Subjects With NPDR

Start: Dec 2015Est. completion: Nov 2019
Phase 2Terminated
NCT01476449GenentechRanibizumab

Dosing Study of Ranibizumab for Diabetic Retinal and Macular Edema

Start: Nov 2011Est. completion: Sep 201620 patients
Phase 2Completed
NCT00701181PfizerLaser Treatment

Study Evaluating Efficacy and Safety of PF-04523655 Versus Laser in Subjects With Diabetic Macular Edema

Start: Jun 2008Est. completion: Jan 2011184 patients
Phase 2Terminated
NCT00387582GenentechRanibizumab

Efficacy Study of Lucentis in the Treatment of Diabetic Macular Edema

Start: Jul 2006Est. completion: Feb 200949 patients
Phase 2Completed
NCT04919499Boehringer IngelheimBI 765128

A Study of BI 765128 in Patients With an Eye Condition Called Diabetic Macular Ischemia Who Have Received Laser Treatment

Start: Jul 2021Est. completion: Aug 202346 patients
Phase 1/2Completed
NCT04424290Boehringer IngelheimBI 764524

HORNBILL: A Study to Test Different Doses of BI 764524 in Patients Who Have Had Laser Treatment for a Type of Diabetic Eye Disease Called Diabetic Retinopathy With Diabetic Macular Ischemia

Start: Jun 2020Est. completion: Apr 202345 patients
Phase 1/2Completed
NCT00211406AlconAnecortave Acetate Sterile Suspension

Treatment of Diabetic Retinopathy With Open-Label Anecortave Acetate Sterile Suspension (15 mg)

Phase 1Terminated
NCT04820621BayerRuncaciguat

Study of the Influence of Liver Function on Blood Concentrations of Runcaciguat in Participants With Different Degrees of Liver Impairment

Start: Apr 2021Est. completion: Jul 20215 patients
Phase 1Terminated
NCT05608265PulseMedicaOSNAT 800 IO

Real-time Eye Tracking and Imaging of the Eye in Diabetic Retinopathy Patients

Start: Aug 2022Est. completion: Mar 202360 patients
N/ACompleted
NCT05417152Notal VisionSingle In-Clinic Encounter With the Notal Vision Home OCT by DME Patients

Single In-Clinic Encounter With the Notal Vision Home OCT by DME Patients

Start: Jun 2022Est. completion: Mar 2023
N/ACompleted
NCT05112445Boehringer IngelheimRetinal Ischemia Characterization in Diabetes - "RICHARD"

Retinal Ischemia Characterization in Diabetes - "RICHARD"

Start: Mar 2022Est. completion: Feb 202660 patients
N/AActive Not Recruiting
NCT04499820Thea PharmaNutrof

Effect of OMEGA3 Supplementation in Diabetic Retinopathy

Start: Jun 2020Est. completion: Apr 2025
N/ACompleted
NCT02232503NovartisStudied cohort

Prevalence of DIAbetic RETinopathy and Impact of Genetic Factors in the Development of Diabetic Retinopathy of Patients With Type 1 and 2 Diabetes Mellitus in SlovaKia

Start: Feb 2015Est. completion: Nov 20154,011 patients
N/ACompleted

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Phase Legend

Preclinical— Lab & animal studies
Phase 1— Safety & dosing
Phase 2— Efficacy testing
Phase 3— Large-scale trials
On Market— Approved & available

Key Insights

5 late-stage (Phase 3) programs — potential near-term approvals
2 actively recruiting trials targeting 6,446 patients
13 companies competing in this space

Related Indications

Myopia(127)Cataract(116)Open-Angle Glaucoma(102)Glaucoma(92)Dry Eye(74)Age-Related Macular Degeneration(73)Dry Eye Disease(43)Neovascular Age-related Macular Degeneration(40)Macular Degeneration(37)Cataracts(22)