A Phase 2 interventional study of ICON-1 and aflibercept in Choroidal Neovascularization and Wet Macular Degeneration, sponsored by Iconic Therapeutics, Inc.. Terminated at 8 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2021-04-13.
Sponsored by Iconic Therapeutics, Inc. · Phase 2, Interventional, and Treatment
Among 88 studies in Choroidal Neovascularization with a site in United States — 2 open to participants now, 9 under way, 4 of them phase 3. Choroidal Neovascularization · United States.
Among the 88 studies in Choroidal Neovascularization with a site in United States, this one is the 67th largest by enrollment of the 77 interventional ones that give a count, is the only one that started in 2018, is one of 23 in phase 2, and was the 76th registered.
214 studies on the registry are indexed under Choroidal Neovascularization; 12 are open to participants now.
Browse Choroidal Neovascularization studies →2 of the 88 studies in Choroidal Neovascularization with a site in United States are open now. Recruiting first, the newest first:
EyeBiotech Ltd. · Sites in United States, Brazil, Colombia and 6 more countries
Ages 50+
EyeBiotech Ltd. · Sites in United States, Argentina, Australia and 9 more countries
Ages 50+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 6 Choroidal Neovascularization studies recruiting now, 4 (67%) set no upper age limit and 0 (0%) stop at 75 or younger; 0 take children under 18; 0 take healthy volunteers.
This study: 50 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
88 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 26 · Phase 2 37 · Phase 3 18 · Phase 4 4
First in 1997; this study’s year is marked. 1 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 15 is below the median of 56 across 160 interventional studies indexed under Choroidal Neovascularization.
Median enrollment 42 across the 77 interventional studies, 77 across the 11 observational. Of the 75 that completed or were terminated, 32 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
50 of 88 have an industry lead sponsor. The 10 most frequent:
Iconic Therapeutics, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
Iconic Therapeutics, Inc. has 2 studies filed under Choroidal Neovascularization — fewer than ten, so there is no comparison to draw.
2 of the studies in Choroidal Neovascularization with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04704921Phase 3AbbViePivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD | 2026-12 |
| NCT06125977University of UtahImpact of Non-Exudative Type 1 MNV on AMD Progression | 2027-08 |
Among the 88 studies in Choroidal Neovascularization with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The purpose of this study is to evaluate the safety and effects of repeated intravitreal injections of ICON-1 0.6 mg administered as maintenance therapy or in combination with aflibercept in patients with wet macular degeneration.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
ICON-1 maintenance therapy after initial aflibercept treatment
Biological: ICON-1 · Biological: aflibercept
ICON-1 combination therapy with aflibercept treatment
Biological: ICON-1 · Biological: aflibercept
ICON-1 0.6 mg by intravitreal injection
Also known as: human Immuno-conjugate 1
aflibercept 2 mg by intravitreal injection
Also known as: Eylea®
Change in Choroidal Neovascularization (CNV) Over Time
Mean change from baseline in CNV area in the study eye
Time frame: Month 9
Change in Best Corrected Visual Acuity (BCVA) Over Time
Mean change from baseline in BCVA letter score in the study eye
Time frame: Month 9
| Milestone | ICON-1 Maintenance Therapy | ICON-1 Combination Therapy |
|---|---|---|
| Started | 7 | 8 |
| Completed | 4 | 4 |
| Not completed | 3 | 4 |
| Withdrew: Withdrawal by subject | 1 | 1 |
| Withdrew: Study terminated | 2 | 3 |
Mean change from baseline in CNV area in the study eye
| participants | ICON-1 Maintenance Therapy | ICON-1 Combination Therapy |
|---|---|---|
| CNV Size-Smaller | 2 | 5 |
| CNV Size-No Change | 2 | 2 |
| CNV Size- Larger | 0 | 1 |
| CNV Size-Cannot Grade | 1 | 0 |
Mean change from baseline in BCVA letter score in the study eye
| Letters | ICON-1 Maintenance Therapy | ICON-1 Combination Therapy |
|---|---|---|
| Change in Best Corrected Visual Acuity (BCVA) Over Time | 1 (-2 to 7) | 0 (-3 to 5) |
Collected over Adverse Events were collected during the study period which included the study period plus 30 days after the last dose for a total period of approximately 10 months for patients who completed the trial.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ICON-1 Maintenance Therapy | 0/7 (0%) | 2/7 (28.6%) | 6/7 (85.7%) |
| ICON-1 Combination Therapy | 0/8 (0%) | 1/8 (12.5%) | 8/8 (100%) |
| Event | ICON-1 Maintenance Therapy | ICON-1 Combination Therapy |
|---|---|---|
| Transient Ischemic Attach (TIA)Vascular disorders | 1/7 | 0/8 |
| SepsisInfections and infestations | 1/7 | 0/8 |
| Metabolic EncephalopathyNervous system disorders | 0/7 | 1/8 |
| UrosepsisInfections and infestations | 0/7 | 1/8 |
| Event | ICON-1 Maintenance Therapy | ICON-1 Combination Therapy |
|---|---|---|
| Subretinal FluidEye disorders | 0/7 | 2/8 |
| Intraocular Pressure IncreasedEye disorders | 1/7 | 2/8 |
| NasopharyngitisInfections and infestations | 0/7 | 2/8 |
| Urinary Tract InfectionInfections and infestations | 0/7 | 2/8 |
| Macular FibrosisEye disorders | 1/7 | 1/8 |
| PhotopsiaEye disorders | 1/7 | 1/8 |
| Retinal HaemorrhageEye disorders | 1/7 | 1/8 |
| Dry eyeEye disorders | 1/7 | 0/8 |
| Lacrimation IncreasedEye disorders | 1/7 | 0/8 |
| MetamorphopsiaEye disorders | 1/7 | 0/8 |
| Age, Customized(Participants) | ICON-1 Maintenance Therapy | ICON-1 Combination Therapy | Total |
|---|---|---|---|
| 50 to <65 Years | 0 | 1 | 1 |
| 65 to<75 Years | 1 | 2 | 3 |
| 75 to <85 | 3 | 3 | 6 |
| 85 Years or older | 3 | 2 | 5 |
| Sex: Female, Male(Participants) | ICON-1 Maintenance Therapy | ICON-1 Combination Therapy | Total |
|---|---|---|---|
| Female | 5 | 4 | 9 |
| Male | 2 | 4 | 6 |
| Ethnicity (NIH/OMB)(Participants) | ICON-1 Maintenance Therapy | ICON-1 Combination Therapy | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 7 | 6 | 13 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | ICON-1 Maintenance Therapy | ICON-1 Combination Therapy | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 7 | 8 | 15 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | ICON-1 Maintenance Therapy | ICON-1 Combination Therapy | Total |
|---|---|---|---|
| United States | 7 | 8 | 15 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2018 to primary completion in Apr 2019, 12 months.
Results were first posted in Mar 2021, 1 year 10 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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Choroidal Neovascularization →
Iconic Therapeutics, Inc.