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Asset Brief

Sozinibercept

OPT·Opthea·Diabetic macular edema (DME)·Phase 1/2·NCT03397264·Primary completion: 26 Mar 2020

Plain-language Brief

The trial in plain terms

The disease: Diabetic macular edema (DME) is a complication of diabetes in which fluid accumulates in the central part of the retina (the macula), causing it to swell and impairing central vision. It is a leading cause of vision loss among working-age adults. The current standard of care involves repeated injections into the eye of drugs that block vascular endothelial growth factor A (VEGF-A), the protein primarily responsible for abnormal blood vessel leakage. A meaningful proportion of patients do not respond fully to VEGF-A blockade alone, leaving residual disease activity.
What the asset is trying to do: Sozinibercept (also referred to as OPT-302) is an Fc-fusion protein — a laboratory-engineered molecule that combines a binding domain with an antibody fragment to extend the drug's active life in the eye. It is designed to block two proteins in the VEGF family, VEGF-C and VEGF-D, which are distinct from VEGF-A and are not targeted by existing approved anti-VEGF-A therapies such as aflibercept (Eylea) or ranibizumab (Lucentis). The proposed approach is to administer sozinibercept alongside an anti-VEGF-A agent rather than as a standalone treatment, with the aim of addressing the additional signalling pathways that VEGF-A-only therapy leaves active (per mechanism profile, Opthea).
What the trial is measuring, and why it matters: The completed Phase 1/2 trial (NCT03397264) was a dose-ranging study evaluating sozinibercept given together with aflibercept in patients with persistent DME (per ClinicalTrials.gov NCT03397264). Trials in DME and related retinal conditions typically assess best-corrected visual acuity (BCVA) — the number of letters a patient can read on a standardised eye chart — as the primary measure of visual benefit, alongside anatomic measures such as central retinal thickness on imaging. These endpoints are established by regulatory precedent for approvals in this disease area.
Efficacy benchmarks in this setting: Approved anti-VEGF-A therapies have established the efficacy bar in DME. In pivotal trials, aflibercept (Eylea) demonstrated a mean gain of approximately 12 letters of BCVA versus sham at one year in treatment-naive DME patients (per Eylea US prescribing information, FDA). Faricimab (Vabysmo), a bispecific antibody approved for DME, showed mean BCVA gains of approximately 10-11 letters versus sham at one year in the YOSEMITE and RHINE Phase 3 trials (per Vabysmo US prescribing information, FDA). Sozinibercept's Phase 1/2 data in DME (NCT03397264) were generated in a dose-ranging, earlier-stage study and are not statistically comparable to the pivotal monotherapy results cited above.
Commercial context: Multiple anti-VEGF-A therapies are approved for DME, including aflibercept (Eylea, Regeneron/Bayer), ranibizumab (Lucentis, Roche/Novartis), bevacizumab (off-label), and faricimab (Vabysmo, Roche/Novartis) (per respective FDA prescribing information). Sozinibercept is not approved in any indication. Opthea's two Phase 3 trials of sozinibercept in neovascular age-related macular degeneration (nAMD) — the ShORe (NCT04757636) and COAST (NCT04757610) trials — were both terminated, each with a target enrolment above 980 patients (per ClinicalTrials.gov NCT04757636 and NCT04757610). The DME indication represented by NCT03397264 was a Phase 1/2 dose-ranging study that has been completed; no subsequent Phase 3 DME programme is identified in the trial data provided.

Sources for this brief (6)

NCT03397264 — A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macular Edema · ClinicalTrials.gov (U.S. National Library of Medicine) · accessed 15 June 2026
NCT04757636 — OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (ShORe) · ClinicalTrials.gov (U.S. National Library of Medicine) · accessed 15 June 2026
NCT04757610 — OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (COAST) · ClinicalTrials.gov (U.S. National Library of Medicine) · accessed 15 June 2026
Eylea (aflibercept) US Prescribing Information · FDA · accessed 15 June 2026
Vabysmo (faricimab) US Prescribing Information · FDA · accessed 15 June 2026
Opthea ASX Announcements · Australian Securities Exchange (ASX) · accessed 15 June 2026

Trial Design

Design summary

Phase: Phase 1/2
Design type: Dose-ranging study. [ TODO: fill in open-label vs blinded, single-arm vs controlled, per NCT03397264 protocol ]
Primary endpoint: [ TODO: fill in per NCT03397264 registry ]
Key secondary endpoints: [ TODO: fill in per NCT03397264 registry ]
Enrolment target: 153 patients (per ClinicalTrials.gov NCT03397264)
Current enrolment status: Completed (per ClinicalTrials.gov NCT03397264; primary completion date 2020-03-26)
Sites: [ TODO: fill in ]
Expected readout window: This trial has completed with a primary completion date of 2020-03-26 (per ClinicalTrials.gov NCT03397264); results have been generated. No active or planned DME trial is identified in the data provided.

Asset Track Record

Did OPT deliver against its own guidance?

Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.

30 June 2026data readoutSozinibercept Phase 3 wet AMD toplineoverdue
2 June 2026otherReinstatement to Official Quotationhitsrc ASX ↗
2 June 2026otherReinstatement to ASX and Update on LAM Development Programhitsrc ASX ↗
30 June 2025financingCapital raise requiredhit · positive
13 Apr 2026data readoutResults posted — OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD)hitsrc
13 Apr 2026data readoutResults posted — A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macularhitsrc
13 Apr 2026data readoutResults posted — OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD)hitsrc
8 Apr 2026data readoutResults posted — A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macularhitsrc

Class Catalyst Calendar

What's landed, what's next for Sozinibercept and peers

Sozinibercept's own upcoming catalysts alongside class-defining historical readouts and upcoming primary completion dates in the same mechanism classes. Each event moves the broader thesis for Sozinibercept. Showing past 6 months and next 12 months · 8 later hidden.

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
Study Evaluating the Efficacy and Safety of Chloroprocaine HCl Ophthalmic Gel 3% vs Proparacaine Ophthalmic Solution 0.5% Plus Subconjunctival Lidocaine in Patients Undergoing Intravitreal Injections

Trial design comparison

How Sozinibercept reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
Sozinibercept	Opthea	Fc Fusion Protein	Phase 1/2[ TODO: fill in ]	Dose-ranging study. [ TODO: fill in open-label vs blinded, single-arm vs controlled, per NCT03397264 protocol ]	[ TODO: fill in per NCT03397264 registry ]	[ TODO: fill in ]	153 patients (per ClinicalTrials.gov NCT03397264)	153
A Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

Mechanism trade-offs· 1 classes comparedexpand ›

Mechanism	Speed to patient	Manufacturing	Best approved result	Durability	Moat
Fc Fusion ProteinFc-fusion trap	Off-the-shelf	Biologic	Eylea / Vabysmo class	Dosing-interval driven	High (incumbents)

OtherASX peers ›

Curated Commentary

Third-party coverage(none curated yet)

expand ›

External analyst notes, journalism, and industry commentary cited with attribution.

No third-party coverage curated for Sozinibercept yet. Broker coverage of Opthea is thin; named analyst notes will appear here as they become available. For now, see the company's ASX announcements and the linked sponsor / class sources elsewhere on this page.

Asset Track Record

Did OPT deliver against its own guidance?

Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.

30 June 2026data readoutSozinibercept Phase 3 wet AMD toplineoverdue
2 June 2026otherReinstatement to Official Quotationhitsrc ASX ↗
2 June 2026otherReinstatement to ASX and Update on LAM Development Programhitsrc ASX ↗
30 June 2025financingCapital raise requiredhit · positive
13 Apr 2026data readoutResults posted — OPT-302 With Ranibizumab in Neovascular Age-related Macular Degeneration (nAMD)hitsrc
13 Apr 2026data readoutResults posted — A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macularhitsrc
13 Apr 2026data readoutResults posted — OPT-302 With Aflibercept in Neovascular Age-related Macular Degeneration (nAMD)hitsrc
8 Apr 2026data readoutResults posted — A Dose Ranging Study of OPT-302 With Aflibercept for Persistent Diabetic Macularhitsrc

Class Catalyst Calendar

What's landed, what's next for Sozinibercept and peers

ConferenceAACR Annual Meeting 2026· ChicagoApr 2026
ConferenceASCO Annual Meeting 2026· ChicagoMay 2026
Today
Study Evaluating the Efficacy and Safety of Chloroprocaine HCl Ophthalmic Gel 3% vs Proparacaine Ophthalmic Solution 0.5% Plus Subconjunctival Lidocaine in Patients Undergoing Intravitreal Injections

Trial design comparison

How Sozinibercept reads against active peer trials

Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.

Trial	Sponsor	Class	Phase / Line	Design	Primary endpoint	Dosing	Key eligibility	n
Sozinibercept	Opthea	Fc Fusion Protein	Phase 1/2[ TODO: fill in ]	Dose-ranging study. [ TODO: fill in open-label vs blinded, single-arm vs controlled, per NCT03397264 protocol ]	[ TODO: fill in per NCT03397264 registry ]	[ TODO: fill in ]	153 patients (per ClinicalTrials.gov NCT03397264)	153
A Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)

Competitor Landscape

Competing programmes by mechanism and phase

Read-across commentary attached per trial. Phase ordering preserved within each group.

Mechanism trade-offs· 1 classes comparedexpand ›

Mechanism	Speed to patient	Manufacturing	Best approved result	Durability	Moat
Fc Fusion ProteinFc-fusion trap	Off-the-shelf	Biologic	Eylea / Vabysmo class	Dosing-interval driven	High (incumbents)

OtherASX peers ›

Soziniberceptn = 153

Opthea·Fc Fusion Protein·Phase 1/2·[ TODO: fill in ]

Design: Dose-ranging study. [ TODO: fill in open-label vs blinded, single-arm vs controlled, per NCT03397264 protocol ]
Primary endpoint: [ TODO: fill in per NCT03397264 registry ]
Dosing: [ TODO: fill in ]
Eligibility: 153 patients (per ClinicalTrials.gov NCT03397264)

A Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)n = —

Alimera Sciences·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Post Marketing Study to Evaluate the Safety and Effectiveness of Brolucizumab in Patients With Diabetic Macular Edema.n = —

Novartis Pharmaceuticals·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Comparing Single Versus Multiple Anti-VEGF Injections in Diabetic Patients Undergoing Cataract Surgeryn = —

Ahmad Zeeshan Jamil·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study Evaluating the Efficacy and Safety of Chloroprocaine HCl Ophthalmic Gel 3% vs Proparacaine Ophthalmic Solution 0.5% Plus Subconjunctival Lidocaine in Patients Undergoing Intravitreal Injectionsn = —

Harrow Inc·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

High Dose Aflibercept in Diabetic Macular Edema in Patients With Previous Vitrectomyn = —

Retina Consultants of Orange County·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Efficacy Comparison of DExamethasone Intravitreal Implant Combined With Aflibercept Versus Aflibercept Monotherapy in Treatment-naïve Inflammatory Diabetic Macular Edema Patientsn = —

Kun Liu·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

High Dose Eylea for Proliferative Diabetic Retinopathy Outcomesn = —

Edward Wood, MD·—·Phase 4

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)n = —

Regeneron Pharmaceuticals·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study to Learn More About How Well 8 Milligram Aflibercept Works and How Safe it is in Chinese Participants With Diabetic Macular Edeman = —

Bayer·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Diabetic Macular Edeman = —

Bio-Thera Solutions·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DMEn = —

Hoffmann-La Roche·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DMEn = —

EyePoint Pharmaceuticals, Inc.·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DMEn = —

EyePoint Pharmaceuticals, Inc.·—·Phase 3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Evaluation of Therapeutic Efficacy of Faricimab for Clinical AMD, DME, and RVO Patientsn = —

Second Affiliated Hospital, School of Medicine, Zhejiang University·—·PHASE2/PHASE3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DMEn = —

EyeBiotech Ltd.·—·PHASE2/PHASE3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DMEn = —

EyeBiotech Ltd.·—·PHASE2/PHASE3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edeman = —

AbbVie·—·PHASE2/PHASE3

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Safety, Tolerability and PK of Subcutaneous D-4517.2 in Subjects With Wet AMD or DMEn = —

Ashvattha Therapeutics, Inc.·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Evaluation of Tonabersat for DMEn = —

Jaeb Center for Health Research·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Phase 2 Study to Evaluate the Efficacy and Safety of ENN0403 in Subjects with DMEn = —

EnnovaBio·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy (DR) With and Without Center Involved-Diabetic Macular Edema (CI-DME)n = —

AbbVie·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edeman = —

Kyowa Kirin Co., Ltd.·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Phase 2a Study to Evaluate the Safety, Tolerability, and Efficacy of SNP318 in DME Patientsn = —

SciNeuro·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A Study to Evaluate the Efficacy and Safety of IBI302 inSubjects With Diabetic Macular Edema（DME）n = —

Innovent Biologics Technology Limited (Shanghai R&D Center)·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)n = —

Sierra Eye Associates·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Study of CU06-1004 in Patients With Daibetic Macular Edeman = —

Curacle Co., Ltd.·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Integrative Liver-Targeted Therapy for Diabetic Macular Edema: Combining Tauroursodeoxycholate and Traditional Chinese Medicine.n = —

University of Alabama at Birmingham·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

4D-150 in Patients With Diabetic Macular Edeman = —

4D Molecular Therapeutics·—·Phase 2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Gene Therapy for DMEn = —

Frontera Therapeutics·—·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

A 2-part Study Consisting of a Multiple Ascending Dose Safety Study in Participants With Macular Edema Following Branch Retinal Vein Occlusion and a Dose-finding Safety and Preliminary Efficacy Study in Participants With Either Diabetic Macular Edema or Neovascular Age-related Macular Degenerationn = —

EyeBiotech Ltd.·—·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

Kamuvudine-9 (K9) in Diabetic Macular Edeman = —

Dr. Bryan Strelow·—·PHASE1/PHASE2

Design: —
Primary endpoint: —
Dosing: —
Eligibility: —

AS
A Study of Intravitreal ILUVIEN® Implant as Baseline Therapy in Patients With Early Diabetic Macular Edema (DME)
Phase 4
Alimera Sciences·Active, not recruiting·Primary completion 31 Dec 2024·NCT04469595
40 sites
N
Post Marketing Study to Evaluate the Safety and Effectiveness of Brolucizumab in Patients With Diabetic Macular Edema.
Phase 4
Novartis Pharmaceuticals·Active, not recruiting·Primary completion 28 Feb 2026·NCT05959304
8 sites
66 enrolled
AZ
Comparing Single Versus Multiple Anti-VEGF Injections in Diabetic Patients Undergoing Cataract Surgery
Phase 4
Ahmad Zeeshan Jamil·Not yet recruiting·Primary completion 30 June 2026·NCT07301775
2 sites
PI: Muhammad Hannan Jamil, FCPS, FRCS, FCPS(VRO)
HI
Study Evaluating the Efficacy and Safety of Chloroprocaine HCl Ophthalmic Gel 3% vs Proparacaine Ophthalmic Solution 0.5% Plus Subconjunctival Lidocaine in Patients Undergoing Intravitreal Injections
Phase 4
Harrow Inc·ENROLLING_BY_INVITATION·Primary completion 1 Aug 2026·NCT07456826
1 site
PI: Samuel Minaker
RC
High Dose Aflibercept in Diabetic Macular Edema in Patients With Previous Vitrectomy
Phase 4
Retina Consultants of Orange County·Recruiting·Primary completion 15 Aug 2026·NCT06662994
1 site
PI: Sean Adrean, M.D
KL
Efficacy Comparison of DExamethasone Intravitreal Implant Combined With Aflibercept Versus Aflibercept Monotherapy in Treatment-naïve Inflammatory Diabetic Macular Edema Patients
Phase 4
Kun Liu·Not yet recruiting·Primary completion 15 Sept 2027·NCT07438119
0 sites
EW
High Dose Eylea for Proliferative Diabetic Retinopathy Outcomes
Phase 4
Edward Wood, MD·Active, not recruiting·Primary completion 1 Feb 2028·NCT07118670
3 sites
R
A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)
Phase 3
Regeneron Pharmaceuticals·Active, not recruiting·Primary completion 26 Aug 2025·NCT06491914
54 sites
1118 enrolledstalled · 286d·PI: Clinical Trial Management
B
A Study to Learn More About How Well 8 Milligram Aflibercept Works and How Safe it is in Chinese Participants With Diabetic Macular Edema
Phase 3
Bayer·Active, not recruiting·Primary completion 29 Dec 2025·NCT06422507
52 sites
333 enrolled
BS
Efficacy Evaluation Study of BAT5906 and Lucentis® in Patients With Diabetic Macular Edema
Phase 3
Bio-Thera Solutions·Recruiting·Primary completion 30 Apr 2027·NCT07515079
HR
A Study to Evaluate Efficacy, Safety & Pharmacokinetics of the Port Delivery System (PDS) With Ranibizumab in Participants With Diabetic Macular Edema (DME) Compared With Intravitreal Ranibizumab; A Substudy to Evaluate the Safety of Re-implanting the PDS With Ranibizumab in Participants With DME
Phase 3
Hoffmann-La Roche·Active, not recruiting·Primary completion 20 July 2027·NCT04108156
88 sites·1 top centre: Johns Hopkins
E,
COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Phase 3
EyePoint Pharmaceuticals, Inc.·Recruiting·Primary completion 1 Oct 2027·NCT07449936
65 sites
E,
CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME
Phase 3
EyePoint Pharmaceuticals, Inc.·Recruiting·Primary completion 1 Oct 2027·NCT07449923
62 sites
SA
Evaluation of Therapeutic Efficacy of Faricimab for Clinical AMD, DME, and RVO Patients
PHASE2/PHASE3
Second Affiliated Hospital, School of Medicine, Zhejiang University·Recruiting·Primary completion 31 Aug 2024·NCT06572553
1 site
PI: Panpan Ye, doctor
E.
A Study to Evaluate the Efficacy and Safety of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME
PHASE2/PHASE3
EyeBiotech Ltd.·Active, not recruiting·Primary completion 30 Sept 2026·NCT06571045
183 sites
984 enrolled·PI: Charles Millershared KOL · Miller
E.
A Study of 2 Doses of EYE103 Compared With Ranibizumab (0.5 mg) in Participants With DME
PHASE2/PHASE3
EyeBiotech Ltd.·Active, not recruiting·Primary completion 1 Mar 2027·NCT06957080
164 sites
1054 enrolled·PI: Charles Millershared KOL · Miller
A
Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema
PHASE2/PHASE3
AbbVie·Recruiting·Primary completion 1 June 2028·NCT07592273
A,
Safety, Tolerability and PK of Subcutaneous D-4517.2 in Subjects With Wet AMD or DME
Phase 2
Ashvattha Therapeutics, Inc.·Active, not recruiting·Primary completion 9 May 2025·NCT05387837
16 sites
JC
Evaluation of Tonabersat for DME
Phase 2
Jaeb Center for Health Research·Active, not recruiting·Primary completion 27 June 2025·NCT05727891
28 sites·2 top centres: Mayo Clinic, Penn / Abramson
E
A Phase 2 Study to Evaluate the Efficacy and Safety of ENN0403 in Subjects with DME
Phase 2
EnnovaBio·Recruiting·Primary completion 1 Dec 2025·NCT06708260
1 site
A
RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy (DR) With and Without Center Involved-Diabetic Macular Edema (CI-DME)
Phase 2
AbbVie·Active, not recruiting·Primary completion 1 June 2026·NCT04567550
25 sites·2 top centres: Johns Hopkins, Duke
139 enrolledstalled · 314d
KK
Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema
Phase 2
Kyowa Kirin Co., Ltd.·Active, not recruiting·Primary completion 31 Aug 2026·NCT06116916
87 sites
PI: Sotaro Takigawa
S
A Phase 2a Study to Evaluate the Safety, Tolerability, and Efficacy of SNP318 in DME Patients
Phase 2
SciNeuro·Not yet recruiting·Primary completion 1 Nov 2026·NCT07199777
0 sites
IB
A Study to Evaluate the Efficacy and Safety of IBI302 inSubjects With Diabetic Macular Edema（DME）
Phase 2
Innovent Biologics Technology Limited (Shanghai R&D Center)·Recruiting·Primary completion 31 Dec 2026·NCT06908876
1 site
150 enrolled
SE
Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)
Phase 2
Sierra Eye Associates·Recruiting·Primary completion 1 Dec 2027·NCT06942520
1 site
PI: Arshad M Khanani
CC
Study of CU06-1004 in Patients With Daibetic Macular Edema
Phase 2
Curacle Co., Ltd.·Not yet recruiting·Primary completion 1 Jan 2028·NCT07459829
0 sites
UO
Integrative Liver-Targeted Therapy for Diabetic Macular Edema: Combining Tauroursodeoxycholate and Traditional Chinese Medicine.
Phase 2
University of Alabama at Birmingham·Not yet recruiting·Primary completion 31 Dec 2028·NCT07457632
1 site
PI: Maria Grant
4M
4D-150 in Patients With Diabetic Macular Edema
Phase 2
4D Molecular Therapeutics·Active, not recruiting·Primary completion 28 Feb 2029·NCT05930561
6 sites
PI: Julie Clark
F
Gene Therapy for DME
PHASE1/PHASE2
Frontera Therapeutics·Recruiting·Primary completion 15 Nov 2024·NCT06492876
E.
A 2-part Study Consisting of a Multiple Ascending Dose Safety Study in Participants With Macular Edema Following Branch Retinal Vein Occlusion and a Dose-finding Safety and Preliminary Efficacy Study in Participants With Either Diabetic Macular Edema or Neovascular Age-related Macular Degeneration
PHASE1/PHASE2
EyeBiotech Ltd.·Active, not recruiting·Primary completion 30 Apr 2026·NCT06664502
DB
Kamuvudine-9 (K9) in Diabetic Macular Edema
PHASE1/PHASE2
Dr. Bryan Strelow·Recruiting·Primary completion 1 June 2026·NCT07458061