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Vitreoretinopathy Proliferative clinical trials

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NCT ID: NCT06166914 Completed - Retinal Detachment Clinical Trials

Efficacy of 5-fluorouracil and Low Molecular Weight Heparin in High-risk Pediatric Retinal Detachment

Start date: October 21, 2021
Phase: N/A
Study type: Interventional

EVALUATION OF 5-FLOUROURACIL AND LOW MOLECULAR WEIGHT HEPARIN INTRAOPERATIVE INFUSION IN PREVENTING PROLIFERATIVE VITREORETINOPATHY IN HIGH RISK PEDIATRIC RHEGMATOGENOUS RETINAL DETACHMENT

NCT ID: NCT04891991 Completed - Retinal Detachment Clinical Trials

Intravitreal Infliximab for Proliferative Vitreoretinopathy

FIXER
Start date: November 26, 2021
Phase: Phase 2
Study type: Interventional

Proliferative vitreoretinopathy (PVR) is the most common cause for failure of rhegmatogenous retinal detachment repair and is characterized by the growth and contraction of cellular membranes within the vitreous cavity on both sides of the retinal surface as well as intraretinal fibrosis. Multiple therapeutic agents have been tried as an adjunctive to retinal detachment surgery for PVR with no consistent efficacy. Tumor necrosis factor-α (TNF-α), which is a prominent inflammatory cytokine, is secreted in response to trauma, infection, and inflammation. It is a key mediator of ocular inflammation and its interactions with the retinal pigment epithelium (RPE) cell contribute to the initiation of PVR. This may occur through the action of TNF-α on the RPE cells inducing changes in cellular morphologies that lead to the formation of fibroblastic cells. Infliximab (Remicade; Janssen Biotech, Horsham, PA, USA) is a mouse-human chimeric antibody that neutralizes the biological activity of TNF-α by high-affinity binding to the soluble and transmembrane forms of TNF-α, therefore preventing the effective binding of TNF-α with its receptors. Infliximab is used in the treatment of various ocular and systemic inflammatory conditions. Furthermore, intravitreal infliximab has been used for the treatment of various ocular diseases and has proven to be generally safe for the short term in inflammatory ocular conditions. A recent study showed that intravitreal infliximab can inhibit the development of PVR and reduce levels of cytokines in an experimental dispase-induced PVR model. The purpose of this randomized controlled trial is to evaluate the efficacy of intravitreal infliximab injection as an adjunct to pars plana vitrectomy in the treatment of PVR associated with primary rhegmatogenous retinal detachment.

NCT ID: NCT04490876 Completed - Clinical trials for Proliferative Vitreoretinopathy

Outcomes of Extensive Brilliant Blue G-Assisted Internal Limiting Membrane Peeling in Proliferative Vitreoretinopathy

ILM
Start date: July 20, 2020
Phase:
Study type: Observational

The aim of this study is to report outcomes of pars plana vitrectomy (PPV) in retinal detachment (RD) accompanied with proliferative vitreoretinopathy (PVR) after extensive Brilliant Blue G-Assisted internal limiting membrane (ILM) peeling using a 3D visualization system. This is retrospective consecutive case series of 14 eyes treated with PPV for RD repair. The patients were follow for 7 to 47 months (mean follow-up: 14.1 months ).

NCT ID: NCT04136366 Completed - Clinical trials for Proliferative Vitreoretinopathy

The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy

Start date: November 15, 2019
Phase: Phase 3
Study type: Interventional

The GUARD Trial is a multi-center, randomized, controlled, adaptive Phase 3 clinical trial of repeated intravitreal injections of ADX-2191 versus standard-of-care for the prevention of proliferative vitreoretinopathy.

NCT ID: NCT03727776 Completed - Clinical trials for Proliferative Vitreoretinopathy

Adrenocorticotropic Hormone (ACTH) for Post-op Inflammation in Proliferative Vitreoretinopathy (PVR)

Start date: August 19, 2019
Phase: Early Phase 1
Study type: Interventional

This is a pilot study to measure levels of albumin and inflammatory cytokines [including Transforming Growth Factor-Beta (TGF-β) and Interleukin-1 Beta (IL-1β)] in the aqueous humor of post-operative proliferative vitreoretinopathy patients receiving subcutaneous injections of H.P. Acthar®, an adrenocorticotropic hormone (ACTH) analog. The study will be conducted at the Wilmer Eye Institute, Johns Hopkins Hospital. A total of 15 patients will be enrolled and randomized 2:1 to H.P. Acthar® or standard of care. Treatment duration will be 8 weeks and study duration will be 12 weeks. There will be a total of 7 study visits (baseline, day of surgery, post-operative day 1, week 1, week 4, week 8, and week 12). Subjects will self-administer subcutaneous injections of 80 units of H.P. Acthar® starting on post-operative day 1 for twice a week until week 8. Subjects in the control arm will be managed per the standard of care. Aqueous samples will be obtained at the onset of surgery, 1 day, 1 week and 8 weeks after surgery. Aqueous levels of albumin and inflammatory cytokines (including TGF-β and IL-1β) will be measured at each time point.

NCT ID: NCT03208205 Completed - Clinical trials for Pediatric Rhegmatogenous Retinal Detachment

Outcomes of Vitrectomy in Pediatric Retinal Detachment With Proliferative Vitreoretinopathy

Start date: January 1, 2006
Phase: N/A
Study type: Observational

The aim of this study is to report outcomes of pars plana vitrectomy (PPV) in pediatric retinal detachment (RD) accompanied with proliferative vitreoretinopathy (PVR) as well as complications and factors influencing the final anatomical and functional results. This is retrospective consecutive case series of 14 eyes treated with primary PPV for RD repair. Average postoperative follow-up period is 34 months.

NCT ID: NCT02865031 Completed - PVR Clinical Trials

Dacorin for Proliferative Vitreoretinopathy

Dacorin
Start date: August 2015
Phase: Phase 1/Phase 2
Study type: Interventional

Purpose: To determine the safety, tolerability, and efficacy of human recombinant decorin protein, a transforming growth factor ß (TGFß) inhibitor in preventing proliferative vitreoretinopathy (PVR) in patients with perforating globe injuries. Methods: This is a prospective, single-center, open-label, interventional case series. A single intravitreal injection of decorin 200ug (n=4) and 400ug (n=8) was given within 24 hours of injury. Pars plana vitrectomy with silicone oil injection was done if indicated. ERG was done before injections, at day 10, and 3 months. Serial plasma decorin levels were assessed before injections, day 3, 5, and 10 post-injection. Clinical assessment included globe survival, retinal attachment rate, and PVR evaluation.

NCT ID: NCT02834559 Completed - Clinical trials for Rhegmatogenous Retinal Detachment

Prophylactic Intravitreal 5-Fluorouracil and Heparin to Prevent PVR in High-risk Patients With Retinal Detachment.

PRIVENT
Start date: October 27, 2016
Phase: Phase 3
Study type: Interventional

This study investigates the effectiveness of a simple treatment to prevent proliferative vitreoretinopathy (PVR). Intraoperative intravitreal 5-fluorouracil (5-FU) and low molecular weight heparin (LMWH) is used as a prophylactic therapy in high-risk patients with primary rhegmatogenous retinal detachment (RRD). Our major motivation is to reduce the incidence of PVR in the group that receives the trial drug.

NCT ID: NCT02192970 Completed - Retinal Detachment Clinical Trials

Bevacizumab Against Recurrent Retinal Detachment

BEARRD
Start date: January 21, 2015
Phase: Phase 2
Study type: Interventional

The investigators hypothesize that bevacizumab instilled into the vitreous after primary retinal detachment surgery will reduce the formation of proliferative vitreoretinopathy and subsequent retinal re-detachment.

NCT ID: NCT01995045 Completed - Retinal Detachment Clinical Trials

Postoperative Pain Control Following Vitreoretinal Surgery

Start date: July 2012
Phase: Phase 4
Study type: Interventional

The aim of this study is to evaluate if patients receiving a steroid (triamcinolone acetonide) combined with local anesthesia and antibiotic following retina surgery have better postoperative pain control those receiving local anesthesia and antibiotic alone.