INV-102 for Diabetic Macular Edema

Overseen By Invirsa Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Invirsa, Inc.

Disqualifiers: Prior laser treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks (NCIDME) / 8 weeks (CIDME)

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is studying an eye drop treatment called INV-102 for diabetic macular edema (DME), a diabetes-related condition that causes vision problems. The researchers aim to determine if these drops can reduce swelling and improve vision in individuals with two types of DME: non-center involved (NCIDME) and center-involved (CIDME). Participants must have diabetes and moderate to severe non-proliferative diabetic retinopathy (NPDR) in the eye being studied, and they should not have received laser treatment on that eye in the past year. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in DME treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatment is likely to be safe?

Research has shown that INV-102 has been tested in people before and has successfully completed at least one previous human trial, indicating a positive safety profile. In earlier studies, INV-102 was used as eyedrops, helping researchers understand how well people can tolerate the treatment.

The current trial focuses on assessing both the safety and effectiveness of INV-102, suggesting it has already demonstrated some safety in past tests. However, new side effects could still emerge.

For those considering joining a trial for INV-102, it is reassuring that the treatment has been tested in people before. Nonetheless, discussing any concerns with a doctor is always advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for diabetic macular edema?

INV-102 is unique because it offers a new approach to treating Diabetic Macular Edema (DME) with its 0.7% ophthalmic solution. Unlike standard treatments like anti-VEGF injections, INV-102 is administered as eye drops, potentially providing a less invasive option with more convenient dosing. Researchers are excited about its potential to target inflammation in the eye, which could lead to improved outcomes for patients with both non-center-involved (NCIDME) and center-involved DME (CIDME). This novel delivery method could enhance patient comfort and compliance while addressing the condition effectively.

What evidence suggests that INV-102 might be an effective treatment for diabetic macular edema?

Research has shown that INV-102 eyedrops are under investigation for their potential to help with diabetic macular edema (DME). This condition involves swelling in the retina caused by diabetes, which can affect vision. Early findings suggest the eyedrops might help reduce this swelling. INV-102 targets specific pathways in the eye that lead to the swelling. Although data remains limited, initial results appear promising for treating both non-center and center-involved DME, where swelling occurs in different parts of the retina. This trial will evaluate INV-102 in two separate parts: one for non-center involved DME and another for center-involved DME. Further studies will help confirm these benefits. ^{4 6 7 8 9}

Who Is on the Research Team?

Robert Shalwitz

Principal Investigator

Invirsa, Inc.

Are You a Good Fit for This Trial?

This trial is for adults with a specific eye condition called non-center involved diabetic macular edema (NCIDME), which is related to diabetes and affects the retina. Participants should have this condition without severe progression that requires immediate surgery.

Inclusion Criteria

My eye condition is due to diabetes but does not affect the center of my retina.

My eye condition is severe due to diabetes but not yet proliferative.

I have diabetes with an A1c level of 12.0% or less.

Exclusion Criteria

I have had laser treatment for diabetic retinopathy in one eye.

I have diabetic macular edema in my study eye.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive INV-102 Ophthalmic Solution for 12 weeks in NCIDME and 8 weeks in CIDME

12 weeks (NCIDME) / 8 weeks (CIDME)

Regular visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• INV-102

Trial Overview The study tests INV-102 eyedrops' effectiveness over 12 weeks in patients with NCIDME associated with non-proliferative diabetic retinopathy, aiming to reduce retinal swelling and improve vision.

How Is the Trial Designed?

Group I: Part 2: INV-102 0.7% in CIDME Experimental Treatment 1 Intervention

INV-102 0.7% Ophthalmic Solution given three times daily (TID) for 2 weeks followed by twice daily (BID) for 6 weeks

Group II: Part 1: INV-102 0.7% in NCIDME Experimental Treatment 1 Intervention

INV-102 0.7% Ophthalmic Solution given three times daily (TID) for 2 weeks followed by twice daily (BID) for 10 weeks

Who Is Running the Clinical Trial?

Invirsa, Inc.

Lead Sponsor

Trials

4

Recruited

310+

Citations

1. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/533415

Study of INV-102 Ophthalmic Solution in Adults With ... Phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during a 12-week dosing period in subjects with ...

2. withpower.com withpower.com/trial/phase-2-retinal-diseases-8-2024-90b53

INV-102 for Diabetic Macular Edema Trial Overview The study tests INV-102 eyedrops' effectiveness over 12 weeks in patients with NCIDME associated with non-proliferative diabetic retinopathy, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2468653024001829

One-Year Anti-VEGF Therapy Outcomes in Diabetic ... This registry analysis found that overall VA and anatomic outcomes tended to be better in DME eyes treated at a greater proportion of visits in the first year ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12184870/

Persistent Diabetic Macular Edema - PubMed Central - NIH Several studies have highlighted the potential for improvement in anatomical and visual outcome when switched to ranibizumab or aflibercept in ...

5. ophthalmologyretina.org ophthalmologyretina.org/article/S2468-6530(24)00182-9/fulltext

One-Year Anti-VEGF Therapy Outcomes in Diabetic ... The mean (95% confidence interval [CI]) VA change after 12 months of treatment was 3.6 (2.8–4.4) letters for eyes in Group A versus 5.2 ...

6. ctv.veeva.com ctv.veeva.com/study/study-of-inv-102-ophthalmic-solution-in-adults-with-non-center-involved-diabetic-macular-edema-assoc

Study of INV-102 Ophthalmic Solution in Adults With Diabetic ... Phase 2 study to assess the efficacy of topically administered eyedrops of INV-102 during a 12-week dosing period in subjects with ...

7. synapse.patsnap.com synapse.patsnap.com/drug/f66524aa69bb4b758a0f9fa45b067c1f

INV-102 - Drug Targets, Indications, Patents The cornea is highly sensitive to SM toxicity and exposure to low vapor doses can cause incapacitating acute injuries. Exposure to higher doses can elicit ...

8. trial.medpath.com trial.medpath.com/clinical-trial/25c93992a8e6d21d/nct06599684-inv-102-ophthalmic-solution-diabetic-macular-edema

Study of INV-102 Ophthalmic Solution in Adults With Diabetic ... 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 ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11514910/

Diabetic macular edema (DME) - PubMed Central - NIH The first-line treatment for DME is anti-VEGF family drugs, such as ranibizumab, brolucizumab, bevacizumab, and aflibercept.