Macular Edema Clinical Trial
Official title:
A Pilot Study With Reduced Fluence Photodynamic Therapy With Visudyne Ranibizumab VS. Ranibizumab Only to Treat Exudative AMD
The purposes of this study is to determine if combination reduced fluence photodynamic
therapy and Ranibizumab has:
Similar efficacy to Ranibizumab (Lucentis) alone. The ability to reduce the number of
intravitreal injection of Ranibizumab or a 13 month period The ability to reduce the number
of PDT treatments. The study will also collect information on the safety of combination
therapy and single therapy.
This will be a 13 month prospective, blinded, randomized sham controled parallel safety
study. There will be 2 treatment arms.
Arm 1 will receive reduced fluence PDT at baseline followed immediately by an intravitreal
injection of Lucentis. Subjects in arm 1 will receive 2 additional injections of Ranibizumab
(Lucentis) over the next 2 months. Starting at month 3, they will receive combination
reduced fluence PDT and intravitreal Ranibizumab (Lucentis) if they develop recurrence of
the subretinal fluid, cystoid macular edema, increased pigment epithelial detachment (PED),
or increased retinal thickness > 100 microns compared to the best prior thickness measure on
OCT. Patients will be eligible for repeat combination reduced fluence PDT + intravitreal
Ranibizumab (Lucentis) every 3 months thereafter. Group 1 patients are eligible for
treatment with combination reduced fluence PDT and Ranibizumab (Lucentis) at any point at
the 3 month time point or thereafter. After month 3, if patients were not eligible for
combined therapy (<3 months since the last combination therapy) and have >2 lines of vision
loss or > 100 microns of increased retinal thickness on OCT compared to most recent measure
at their monthly visit, they would be eligible for an injection of Ranibizumab (Lucentis) as
monotherapy. Thereafter, subjects will have combination therapy if retreatment criteria were
met and it has been >3 months since the last PDT treatment.
Study arm 2 will receive 3 monthly intravitreal injections of Ranibizumab (Lucentis).
Following month 2, they will be eligible for re-treatment with Ranibizumab (Lucentis) if
retreatment criteria are met (same criteria as study arm 1). At intervals of no less than 3
months from the previous sham PDT, they will receive sham PDT if retreatment criteria are
met.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04292912 -
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2798745 in Participants With Diabetic Macular Edema
|
Phase 1 | |
Recruiting |
NCT05976139 -
Micropulsed Laser in Patients With Macular Oedema in Retinal Dystrophies
|
N/A | |
Completed |
NCT03660371 -
ILM Peeling in PDR Patients Undergoing PPV for VH
|
N/A | |
Completed |
NCT03660345 -
PPV With Internal Limiting Membrane Peeling for Treatment-Naïve DME
|
Phase 3 | |
Completed |
NCT01660802 -
Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)
|
Phase 3 | |
Completed |
NCT01908816 -
An Open-label Extended Clinical Protocol of Ranibizumab to Evaluate Safety and Efficacy in Rare VEGF Driven Ocular Diseases.
|
Phase 3 | |
Completed |
NCT04592419 -
A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)
|
Phase 3 | |
Completed |
NCT02867735 -
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Activity of Intravitreal LKA651 in Patients With Macular Edema
|
Phase 1 | |
Completed |
NCT02623673 -
Simultaneous Therapy With Intravitreal Dexamethasone Implant and Bevacizumab for the Treatment of Macular Edema
|
N/A | |
Terminated |
NCT01946399 -
Ozurdex Implant for Macular Edema After Treatment Failure With Anti-VEGF
|
N/A | |
Completed |
NCT01428388 -
Bevacizumab Versus Ranibizumab in Treatment of Macular Edema From Vein Occlusion
|
N/A | |
Completed |
NCT01231633 -
Comparison of Initial Ozurdex (Dexamethasone Implant) to Avastin (Bevacizumab) for Treatment of Macular Edema Caused by Central Retinal Vein Occlusion (CRVO)
|
N/A | |
Recruiting |
NCT01023113 -
To Compare Visual Field Impairment in Conventional Double Frequency Nd: YAG Panretinal Photocoagulation With PASCAL Panretinal Photocoagulation
|
N/A | |
Terminated |
NCT00918554 -
Efficacy Study of Methotrexate to Treat Sarcoid-associated Uveitis
|
Phase 4 | |
Terminated |
NCT00969293 -
Study to Assess the Safety and Tolerability of a Single Administration of FOV2302 (Ecallantide) in Patients With Macular Edema Associated With Central Retinal Vein Occlusion
|
Phase 1 | |
Completed |
NCT00970957 -
Safety and Effectiveness of Bevacizumab Intravitreal Injections in the Treatment of Macular Edema Secondary to Retinal Vein Occlusion
|
Phase 3 | |
Completed |
NCT00476593 -
Retinal OCT and (mfERG) Related to Age, Sex, and the Use of Anti-inflammatory Medications
|
N/A | |
Completed |
NCT00411970 -
20- Versus 23- Gauge System for Pars Plana Vitrectomy
|
Phase 4 | |
Completed |
NCT00668239 -
Diffuse Diabetic Maculopathy With Intravitreal Triamcinolone or Laser
|
N/A | |
Terminated |
NCT01939691 -
Macular Edema Nepafenac vs. Difluprednate Uveitis Trial
|
Phase 4 |