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NCT07440186

Exploratory Clinical Research for the Evaluation of Human GMP (Good Manufacturing Practice) Collagen Implants (Humabiologics) in the Treatment of Corneal Melting (RCJ-COL3D-MC-01-2026)

Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

View on ClinicalTrials.gov

Summary

Participants will be invited to participate in this clinical study because they have a severe corneal melting. An eye disease characterized by the progressive loss of the transparent tissue that covers the eye (the cornea). This condition can cause pain, vision loss, and risk of eye perforation. Furthermore, in some cases, the response to standard treatments is inadequate. A piece of 3D-printed human collagen will be implanted on the affected surface of the eye in order to reinforce and protect it and prevent its progression to perforation. The collagen piece is biocompatible, flexible, and transparent, designed to integrate naturally with the eye's tissues. Since it does not require a complete transplant or a human donor at the time of surgery, it reduces the risks of rejection and complications associated with other more invasive techniques.

Official title: Exploratory Clinical Research for the Evaluation of Human GMP Collagen Implants (Humabiologics) in the Treatment of Corneal Melting.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-02-28

Completion Date

2027-01-31

Last Updated

2026-02-27

Healthy Volunteers

Conditions

Patients With Severe Corneal Melting

Interventions

DEVICE

3D collagen implant printed under GMP conditions.

Given its exploratory nature, the study does not propose an equivalence threshold compared to standard treatments, but rather seeks to confirm the safety and clinical viability of the implant. It is expected that 3D-printed collagen will provide superior stromal support, with greater transparency and stability than other reconstructive techniques, such as amniotic membrane, conjunctival flaps, or tectonic grafts.

Inclusion Criteria: 1. Age over 18 years. 2. Patients who, after receiving detailed information about the design, purpose, risks, and implications of the study, and about their right to withdraw at any time without repercussions, give their informed written consent. 3. Confirmed diagnosis of severe corneal melting. 4. Absence of response to conventional non-surgical treatments, which must include: * Intensive antibiotic, antifungal, or antiviral treatment according to etiology. * Anti-inflammatory or immunomodulatory eye drops (such as corticosteroids, cyclosporine, tacrolimus). * Intensive lubrication and/or autologous serum. * Use of therapeutic contact lenses. * The patient must not have responded satisfactorily to these measures and must show progression or persistence of the ulcer, thinning, and structural risk. The absence of response is not defined by a specific number of treatments, but by the lack of clinical improvement or progression of the condition despite having received several of these measures appropriately. In particular, progression of the epithelial defect, worsening stromal thinning, or the appearance of signs of perforation risk will be considered an absence of response, which would justify surgical intervention. 5. If the patient has previously undergone surgical procedures or received other implants (such as amniotic membrane, conjunctival flap, or Tenon's graft), this will be included if there is documented clinical progression without sufficient functional or structural recovery, and provided that there are no surgical alternatives with documented superior efficacy in their specific situation. Exclusion Criteria: 1. Pregnancy or breastfeeding. 2. Refusal to participate in the study. 3. Presence of active eye infection. 4. Systemic diseases that may affect healing. 5. Known hypersensitivity to collagen compounds. 6. Any circumstance that, in the investigator's opinion, makes the patient's participation in the clinical research inadvisable.