Non-center Involved Diabetic Macular EdemaPhase 2NCT06599684
Study of INV-102 Ophthalmic Solution in Adults With Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy
A Phase 2 study testing INV-102 in people with Non-center Involved Diabetic Macular Edema and Non-center Involved Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy, run by Invirsa, Inc. at 1 site in United States.
Trial summary
Phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during a 12-week dosing period in subjects with non-center involved DME (NCIDME) associated with NPDR [Part 1] and during an 8-week dosing period in subjects with center-involved DME (CIDME) associated with NPDR [Part 2]. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-center Involved Diabetic Macular Edema, Non-center Involved Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy, Diabetic Retinopathy
- What is being tested?
- INV-102
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2024to 30 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects ≥ 18 years of age and < 76 years of age
- Diagnosed with diabetes (Type 1 or 2) with hemoglobin A1c ≤ 12.0%
- Study eye must have NCIDME (Part 1) or CIDME (Part 2)
- Study eye must be moderate to severe NPDR
Who cannot join
- Prior laser treatment for DR in the study eye within 12 months from Screening Visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2a Pilot, Open Label, Multicenter, Study of INV-102 Ophthalmic Solution in Subjects With Diabetic Macular Edema (DME) Associated With Non-proliferative Diabetic Retinopathy (NPDR)
Phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during a 12-week dosing period in subjects with non-center involved DME (NCIDME) associated with NPDR [Part 1] and during an 8-week dosing period in subjects with center-involved DME (CIDME) associated with NPDR [Part 2].
- Conditions
- Non-center Involved Diabetic Macular Edema, Non-center Involved Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy, Diabetic Retinopathy, Center-involved Diabetic Macular Edema, Center-involved Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy
- Being tested
- INV-102
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
INV-102Drug
0.7% Ophthalmic Solution
| Study group | Role | What they receive |
|---|---|---|
| Part 1: INV-102 0.7% in NCIDME | Experimental | INV-102 0.7% Ophthalmic Solution given three times daily (TID) for 2 weeks followed by twice daily (BID) for 10 weeks Receives: Drug: INV-102 |
| Part 2: INV-102 0.7% in CIDME | Experimental | INV-102 0.7% Ophthalmic Solution given three times daily (TID) for 2 weeks followed by twice daily (BID) for 6 weeks Receives: Drug: INV-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Early Treatment Diabetic Retinopathy (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) score
Graded by an independent central reading center using Wide-field Color Fundus Photography. The DRSS divides diabetic retinopathy into levels ranging from absence of retinopathy (score = 10) to advanced retinopathy (score = 85). The scale is used to describe overall retinopathy severity as well as the change in severity over time.
Measured: Day 84 (Part 1) and Day 56 (Part 2)
Change from baseline in central subfield thickness (Part 2 only)
Measured using spectral domain optical coherence tomography (SD-OCT) and determined by an independent central reading center.
Measured: Day 56
Secondary outcomes (4)
Change from baseline in macular volume
Measured using spectral domain optical coherence tomography (SD-OCT)
Measured: Day 84 (Part 1) and Day 56 (Part 2)
Change from baseline in subfield thickness
Mean retinal thickness in each of the regional subfields of the ETDRS grid, measured using SD-OCT
Measured: Day 84 (Part 1) and Day 56 (Part 2)
Change from baseline in the retinal thickness at the thickest point of the subfield thickness
Measured using SD-OCT in each of the regional subfields of the ETDRS grid
Measured: Day 84 (Part 1) and Day 56 (Part 2)
Change in best corrected visual acuity (BCVA) (Part 2 only)
Measured: Day 56
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start7 Sep 2024
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-center Involved Diabetic Macular EdemaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Invirsa, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Responsible party
- Sponsor
- Investigators
- Robert Shalwitz, Study chair, Invirsa, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599684
- Sponsor's protocol ID
- INV-102-CS-004
- Other IDs
- 75A50120C00171
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2024
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2a Pilot, Open Label, Multicenter, Study of INV-102 Ophthalmic Solution in Subjects With Diabetic Macular Edema (DME) Associated With Non-proliferative Diabetic Retinopathy (NPDR)
- ClinicalTrials.gov ID
- NCT06599684
- Acronym / sponsor ID
- INV-102-CS-004
- Conditions
- Non-center Involved Diabetic Macular Edema, Non-center Involved Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy, Diabetic Retinopathy, Center-involved Diabetic Macular Edema, Center-involved Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Invirsa, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Biomedical Advanced Research and Development Authority
- Study start
- 7 Sep 2024 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during a 12-week dosing period in subjects with non-center involved DME (NCIDME) associated with NPDR [Part 1] and during an 8-week dosing period in subjects with center-involved DME (CIDME) associated with NPDR [Part 2].
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1: INV-102 0.7% in NCIDME | Experimental | Drug: INV-102INV-102 0.7% Ophthalmic Solution given three times daily (TID) for 2 weeks followed by twice daily (BID) for 10 weeks |
| Part 2: INV-102 0.7% in CIDME | Experimental | Drug: INV-102INV-102 0.7% Ophthalmic Solution given three times daily (TID) for 2 weeks followed by twice daily (BID) for 6 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects ≥ 18 years of age and < 76 years of age
- Diagnosed with diabetes (Type 1 or 2) with hemoglobin A1c ≤ 12.0%
- Study eye must have NCIDME (Part 1) or CIDME (Part 2)
- Study eye must be moderate to severe NPDR
Key exclusion criteria (1 listed)
- Prior laser treatment for DR in the study eye within 12 months from Screening Visit
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 |
|---|---|---|
| INV-1020.7% Ophthalmic Solution | Drug | Part 1: INV-102 0.7% in NCIDME, Part 2: INV-102 0.7% in CIDME |
Primary outcome
Change from baseline in the Early Treatment Diabetic Retinopathy (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) score
Time frame: Day 84 (Part 1) and Day 56 (Part 2)
Graded by an independent central reading center using Wide-field Color Fundus Photography. The DRSS divides diabetic retinopathy into levels ranging from absence of retinopathy (score = 10) to advanced retinopathy (score = 85). The scale is used to describe overall retinopathy severity as well as the change in severity over time.
Change from baseline in central subfield thickness (Part 2 only)
Time frame: Day 56
Measured using spectral domain optical coherence tomography (SD-OCT) and determined by an independent central reading center.
4 secondary outcomes
Change from baseline in macular volume
Time frame: Day 84 (Part 1) and Day 56 (Part 2)
Change from baseline in subfield thickness
Time frame: Day 84 (Part 1) and Day 56 (Part 2)
Change from baseline in the retinal thickness at the thickest point of the subfield thickness
Time frame: Day 84 (Part 1) and Day 56 (Part 2)
Change in best corrected visual acuity (BCVA) (Part 2 only)
Time frame: Day 56
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
Related trials for Non-center Involved Diabetic Macular Edema
RecruitingObservational study
Non-Center Involving Diabetic Macular Edema Progression in Early Postoperative Period After Phacoemulsification
Non-Center, Diabetic Macular Edema
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.
Robert Shalwitz study chair
Invirsa, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing INV-102 in people with Non-center Involved Diabetic Macular Edema and Non-center Involved Diabetic Macular Edema Associated With Non-proliferative Diabetic Retinopathy, run by Invirsa, Inc. at 1 site in United States.
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 4 inclusion and 1 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 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in the Early Treatment Diabetic Retinopathy (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) score (time frame: Day 84 (Part 1) and Day 56 (Part 2)). 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?
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 2 Oct 2026.