SOL-X

19 evidence topics · 4 sources

Objective

Registered official title

“A Phase 3b, Multicenter, Open-Label, Extension Study to Evaluate Long-Term Safety of Intravitreal OTX-TKI (Axitinib Implant) in Participants With Neovascular Age-Related Macular Degeneration Who Successfully Completed 2-Year OTX-TKI-2023-AMD-301 or OTX-TKI-2023-AMD-303 Study” (opens the source at this quote in a new tab)

Company-stated primary objectives

“The primary objectives of SOL-X are to evaluate the long-term safety of AXPAXLI; to explore long-term visual outcomes, including visual acuity and the incidence and/or progression of fibrosis and macular atrophy; and to evaluate the impact of delayed initiation of AXPAXLI in patients who initially were randomized to receive aflibercept in either SOL-1 or SOL-R.” (opens the source at this quote in a new tab)

Location and study date

Registry dates and status

Milestone	Registry record
Study start (actual)	“2026-04-27”
Primary completion (estimated)	“2030-08-01”
Study completion (estimated)	“2030-08-01”
Last verified	“2026-06”

Registry sites

“This study has 8 locations” (opens the source at this quote in a new tab)

Site
“California Retina Consultants (CRC)”
“Retina Group of New England”
“Retina Group of Florida - Fort Lauderdale”
“Cumberland Valley Retina Associates”
“Mid Atlantic Retina Specialists”
“Palmetto Retina Center”
“Austin Retina Associates”

Company-reported first enrollment

“In April 2026, the first patient was enrolled in the SOL-X trial, a multi-center, open-label, long-term safety extension clinical trial to evaluate subjects who have completed their two-year safety follow-up visits in either the SOL-1 or SOL-R trial for an additional three years.” (opens the source at this quote in a new tab)

Study design

Registered design

Field	Registry record
Allocation	“N/A”
Interventional model	“Single Group Assignment”
Masking	“None (Open Label)”

Company-described design: 36-month open-label extension

“The SOL-X trial (NCT07516132) is a multi-center, 36-month open-label extension trial designed to evaluate the long-term safety, efficacy, and disease modifying potential of AXPAXLI in wet AMD for subjects who have successfully completed their two-year safety follow-up visits in either the SOL-1 or SOL-R trials.” (opens the source at this quote in a new tab)

Visit schedule

“Subjects are assessed at Week 4, Week 12, and then every 12 weeks thereafter. Additional visits can be conducted with supplemental anti-VEGF injection administered based on investigator discretion.” (opens the source at this quote in a new tab)

Eligibility criteria

Registered inclusion criteria

“Participants with a diagnosis of nAMD in the study eye who successfully completed Study OTX-TKI-2023-AMD-301 through Week 104 or Study OTX-TKI-2023-AMD-303 through Week 96” (opens the source at this quote in a new tab)
“Have adequate ocular media and adequate pupillary dilation in the study eye to permit good quality fundus imaging” (opens the source at this quote in a new tab)
“Are able and willing to comply with all study requirements and visits” (opens the source at this quote in a new tab)
“Have provided written informed consent” (opens the source at this quote in a new tab)

Registered exclusion criteria

“Have significant intraocular or periocular infection (bacterial, viral, or fungal) in the study eye within 3 months prior to Day 1” (opens the source at this quote in a new tab)
“History of intraocular inflammation in the study eye” (opens the source at this quote in a new tab)
“Have evidence of a rhegmatogenous retinal detachment or visually significant/severe epiretinal membrane, macular hole, tear of the retinal pigment epithelium in the macula, or other macular” (opens the source at this quote in a new tab)
“Presence of an intercurrent illness or condition that in the opinion of the Investigator, may place the participant at an unacceptable risk, preventing the participant from completing the study or confound the interpretation of study results” (opens the source at this quote in a new tab)

Age

Field	Registry record
Ages eligible for study	“50 Years and older”

Treatment

Dosing every 24 weeks for all participants

“According to the trial design, all subjects will be given AXPAXLI every 24 weeks, starting at Day 1 (after completion of the Week 104 visit in SOL-1, or Week 96 visit in SOL-R), and again at Weeks 24, 48, 72, 96, and 120.” (opens the source at this quote in a new tab)

“Subjects enrolled in the SOL-X trial will receive AXPAXLI 450 μg every 24 weeks and are to be evaluated at Week 4, Week 12, and every 12 weeks thereafter.” (opens the source at this quote in a new tab)

Registered intervention

“Intravitreal Injection of OTX-TKI” (opens the source at this quote in a new tab)

Study outcomes

Rationale for using treatment-emergent adverse events and severe vision loss as the primary endpoints

Registered primary outcome measures

“Incidence and severity of treatment-emergent adverse events (TEAEs) from Baseline (Day 1) through Week 144” (opens the source at this quote in a new tab)
“Proportion of participants with severe vision loss (defined as ≥ 30 Early Treatment Diabetic Retinopathy Study [ETDRS] letters loss) from Baseline (Day 1) through Week 144” (opens the source at this quote in a new tab)

Company hypothesis for long-term outcomes

“Ocular believes sustained VEGF suppression with AXPAXLI may reduce the incidence of fibrosis and atrophy in wet AMD, thereby improving long-term outcomes.” (opens the source at this quote in a new tab)

Rationale for delayed-initiation comparison

“SOL-X outcomes may further expand AXPAXLI’s potential by highlighting the need to start AXPAXLI treatment early or risk worse long-term visual outcomes due to potential fibrosis and atrophy that may be seen with pulsatile treatments.” (opens the source at this quote in a new tab)

Secondary outcome measures and definitions of fibrosis and atrophy

No evidence found.

Statistical analysis description

Number of participants (Planned and analyzed)

Registry estimated enrollment

Field	Registry record
Enrollment (estimated)	“850”

Company-reported enrollment status

“SOL-X (wet AMD) enrollment continues to accelerate, with the vast majority of trial investigators and eligible patients opting to participate in the open-label extension study.” (opens the source at this quote in a new tab)

Description of analysis sets

No evidence found.

Results

Participant disposition

No evidence found.

Baseline characteristics

No evidence found.

Efficacy results

No evidence found.

Health-related quality of life and patient-reported outcomes

No evidence found.

Safety results

No evidence found.

Study limitations

Summary

SOL-X is a single-group, open-label extension with no concurrent control and no reported results; its primary outcomes (treatment-emergent adverse events and loss of at least 30 letters through Week 144) are estimated to complete on 2030-08-01. Enrollment is limited to participants who completed 2 years of SOL-1 or SOL-R, which selects for participants who tolerated and remained in the parent trials. Evaluation of delayed initiation compares participants originally randomized to aflibercept with those originally randomized to the axitinib implant, but in SOL-X both groups receive the implant every 24 weeks without masking, and supplemental anti-VEGF injections are permitted at investigator discretion. The registry lists an estimated 850 participants at 8 United States sites, and no definitions of fibrosis or macular atrophy endpoints were identified.