Treatment of diabetic macular edema and wet age-related macular degeneration in the eye with a substance suppressing a growth factor (TGF-Beta2)

Phase 1

• Conditions: eovascular age-related macular degeneration (nAMD)Diabetic Macular edema (DME); MedDRA version: 20.1Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 100000004853; MedDRA version: 20.0Level: LLTClassification code 10075568Term: Wet age-related macular degenerationSystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2021-001213-36-AT
• Lead Sponsor: Isarna Therapeutics GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Patients must provide written informed consent before any study related procedures are performed
2.Patients must be =18 yrs in the DME cohort and = 50 in the nAMD cohort at Screening
Study eye nAMD:
3.Active CNV lesions secondary to nAMD (including retinal angiomatous proliferation lesions with a CNV component) in the study eye at Screening in treatment naïve nAMD arm.
4.About 50% of the patients in the AMD treatment naïve group should have classic or predominantly classic CNV / Type II CNV or hemorrhage
5.Pretreated CNV lesions secondary to nAMD (including retinal angiomatous proliferation lesions with a CNV component) in the study eye at Screening in pretreated nAMD. About 50% of the patients should be included with SHRM present on OCT despite anti-VEGF therapy or hemorrhage present at initial diagnosis/ therapy start
6. Intra- and/or subretinal fluid affecting the central subfield of the study eye at Screening with CMT =305 µm in women, and =320µm in men or with a center point thickness of >260 in women and >270 micrometer in men as measured by SD-OCT in treatment naïve nAMD arm
7.For treatment naïve patients, BCVA between 83 and 23 letters, inclusive, in the study eye at Screening and Baseline using early treatment diabetic retinopathy study (ETDRS) testing.
8.For Treatment naïve and VEGF primed group: Treatment naïve nAMD in study eye
9.For VR-group: Dry or =50 micrometer SRF in vertical extension after receiving 1-6 anti-VEGF injections. Diagnosis no longer than 9 months before Baseline
Study eye DME:
10.Active CME secondary to diabetes in the study eye at Screening in treatment naïve DME.
11.Intra- and/or subretinal fluid affecting the central subfield of the study eye at Screening with CMT =305 µm in women, and =320µm in men or with a center point thickness of >260 in women and >270 micrometer in men as measured by SD-OCT in treatment naïve DME arm.
12.For treatment naïve patients, BCVA between 83 and 23 letters, inclusive, in the study eye at Screening and Baseline using early treatment diabetic retinopathy study (ETDRS) testing.
13.Moderate to severe NPDRP assessed via ETDRS severity scale and mild PDRP (with 1 NVE) in study eye (diabetic retinopathy severity scale DRSS 43-61)
14.Absence of prior PRP treatment
15.For Treatment naïve group: Treatment naïve DME in study eye
16.For VR-group: History of CME secondary to diabetes in the study eye with complete resolution of IRF and/or SRF or a =20% reduction in CMT secondary to diabetes after receiving 1-6 monthly anti-VEGF injections over the last 9 months
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

1.Any active intraocular or periocular infection or active intraocular inflammation (e.g., infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis) in either eye at BL
2.Presence of amblyopia, amaurosis or ocular disorders in the fellow eye with BCVA < 35 ETDRS letters at Scr (except when due to conditions whose surgery may improve visual acuity, e.g., cataract)
3.nAMD diagnosed for more than 9 mon
4.Poor quality of SD-OCT images at Scr or BL
5.Central subfield of the study eye affected by geographic atrophy assessed by OCT, color fundus photography (CFP) and fundus autofluorescence (FAF) at Scr
6.Subretinal blood affecting the central subfield and/or = 50% of the lesion of the study eye at Scr
7.Concomitant conditions or ocular disorders in the study eye, including retinal diseases other than nAMD, that, in the judgment of the investigator, could require medical or surgical intervention during the study to prevent or treat visual loss that might result from that condition, or that limits the potential to gain visual acuity upon treatment with the investigational product
8.Structural damage within 0.5-disc diameter of the center of the macula in the study eye, e.g., vitreomacular traction, epiretinal membrane, retinal pigment epithelium (RPE) rip/tear scar, laser burn, at the time of Scr that in the investigator’s opinion could preclude visual function improvement with treatment
9.Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to BL
10.Uncontrolled glaucoma in the study eye defined as IOP > 25 mmHg on medication or according to the investigator’s judgment at Scr or BL
11.Aphakia and/or complete of the posterior capsule in the study eye at Scr
12.For Treatment naïve and VEGF primed group:Any prior treatment for nAMD in study eye
13.For VR-group: > 50 micrometer SRF in vertical extension after receiving 1-6 anti-VEGF injections over the last 9 mon
14.For VR-group: > 6 anti-VEGF injections
15.Treatment requiring DME diagnosed for more than 9 mon
16.Poor quality of SD-OCT images
17.Focal laser scars within the central 1 mm ETDRS subfield
18.Concomitant conditions or ocular disorders in the study eye, including retinal diseases other than DME, that, in the judgment of the investigator, could require medical or surgical intervention during the study to prevent or treat visual loss that might result from that condition, or that limits the potential to gain visual acuity upon treatment with the investigational product
19.Structural damage within 0.5-disc diameter of the center of the macula in the study eye, e.g., vitreomacular traction, epiretinal membrane, retinal pigment epithelium (RPE) rip/tear scar, laser burn, at the time of Scr that in the investigator’s opinion could preclude visual function improvement with treatment
20.Current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior BL
21.Uncontrolled glaucoma in the study eye defined as IOP > 25 mmHg on medication or according to the investigator’s judgment at Scr or BL
22.Moderate and severe PDRP requiring PRP in study eye
23.Prior PRP treatment in study eye
24.Aphakia and/or complete of the posterior capsule in the study eye at Scr
25.For Treatment naïve group: Any prior treatment for DME in study eye
26.For VR-group: <20% reduction in CMT after receiving 1-6 monthly anti-VEGF injections over the last 9 mon after diagnosis.
27.For VR-group: > 6 anti-VEGF inje

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified