deltatrials
Active Not Recruiting PHASE2 INTERVENTIONAL 6-arm NCT04567550

RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy (DR) With and Without Center Involved-Diabetic Macular Edema (CI-DME) (ALTITUDE®)

A Phase 2, Randomized, Controlled, Dose-escalation Study to Evaluate the Efficacy, Safety, and Tolerability of RGX-314 Gene Therapy Delivered Via a Single Suprachoroidal Space (SCS) Injections in Participants With Diabetic Retinopathy (DR) With and Without Center Involved-Diabetic Macular Edema (CI-DME)(ALTITUDE)

Sponsor: AbbVie

Conditions Center-Involved Diabetic Macular Edema (CI-DME) Diabetic Retinopathy (DR)
Interventions ABBV-RGX-314 Dose 1 ABBV-RGX-314 Dose 2 ABBV-RGX-314 Dose 3 ABBV-RGX-314 Dose 4 Aflibercept Topical Steroid
Updated 15 times since 2020 Last updated: Sep 15, 2025 Started: Nov 20, 2020 Primary completion: Jun 30, 2026 Completion: Dec 31, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04567550, this PHASE2 trial focuses on Center-Involved Diabetic Macular Edema (CI-DME) and Diabetic Retinopathy (DR) and remains ongoing. Sponsored by AbbVie, it has been updated 15 times since 2020, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Oct 2020 – ~Nov 2020 · 31 days · monthly snapshot~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshot~Dec 2021 – ~Apr 2022 · 4 months · monthly snapshot~Apr 2022 – ~Sep 2022 · 5 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jun 2023 · 6 months · monthly snapshot~Jun 2023 – ~Jul 2024 · 13 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Apr 2025 · 7 months · monthly snapshot~Apr 2025 – ~Aug 2025 · 4 months · monthly snapshot~Aug 2025 – ~Oct 2025 · 2 months · monthly snapshot~Oct 2025 – present · 10 months · monthly snapshot

Change History

15 versions recorded

  1. Oct 2025 — Present [monthly]

    Active Not Recruiting PHASE2

  2. Aug 2025 — Oct 2025 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  3. Apr 2025 — Aug 2025 [monthly]

    Recruiting PHASE2

  4. Sep 2024 — Apr 2025 [monthly]

    Recruiting PHASE2

  5. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE2

▶ Show 10 earlier versions

  1. Jun 2023 — Jul 2024 [monthly]

    Recruiting PHASE2

  2. Dec 2022 — Jun 2023 [monthly]

    Recruiting PHASE2

    Status: Active Not Recruiting → Recruiting

  3. Nov 2022 — Dec 2022 [monthly]

    Active Not Recruiting PHASE2

  4. Sep 2022 — Nov 2022 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  5. Apr 2022 — Sep 2022 [monthly]

    Recruiting PHASE2

  6. Dec 2021 — Apr 2022 [monthly]

    Recruiting PHASE2

  7. Jan 2021 — Dec 2021 [monthly]

    Recruiting PHASE2

  8. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

  9. Nov 2020 — Dec 2020 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  10. Oct 2020 — Nov 2020 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • AbbVie
  • REGENXBIO Inc.
Data source: AbbVie

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Abilene, United States , Albuquerque, United States , Augusta, United States , Austin, United States , Bakersfield, United States , Baltimore, United States , Beverly Hills, United States , Boston, United States , Burleson, United States , Campbell, United States and 14 more locations