Patients with neovascular (wet) age-related maculardegeneration phase I multi-center, open label, single-arm study to evaluate the safety of R-TPR-023.
- Conditions
- Health Condition 1: H512- Internuclear ophthalmoplegia
- Registration Number
- CTRI/2023/09/057394
- Lead Sponsor
- Reliance life sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1. Male or female patients of age = 50 years.
2. Active primary or recurrent subfoveal lesions with classic or occult choroidal
neovascularization (CNV) secondary to age-related macular degeneration (AMD) in
the study eye.
3. Best corrected visual acuity, using Early Treatment of Diabetic Retinopathy Study
(ETDRS) charts, of 20/40 to 20/320 (Snellen equivalent) in the study eye.
4. Able to understand the study procedures and the risks involved, willing to provide
written Informed Consent, and able to adhere to study schedules and requirements.
5. Menopausal females must have experienced their last period at least 12 months prior
to study entry to be classified as not of childbearing potential. Men and women of child
bearing potential must be practicing effective contraception implemented during the
trial and for at least 60 days following the last dose of study medication.
1. Treatment with verteporfin photodynamic therapy in the study eye within 6 months or
in the non-study eye within 1 week prior to randomization.
2. Previous external-beam radiation therapy, trans-pupillary thermotherapy or subfoveal
focal laser photocoagulation in the study eye.
3. Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month
prior to randomization.
4. CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or
pathologic myopia.
5. History of submacular surgery or other surgical intervention for AMD, previous
intravitreal drug delivery or vitrectomy surgery in the study eye.
6. Current vitreous haemorrhage, subretinal hemorrhage that involves the fovea,
subfoveal fibrosis or atrophy, active intraocular inflammation or infection in the study
eye
7. History of retinal pigment epithelial tear, rhegmatogenous retinal detachment or
macular hole (Stage 3 or 4), aphakia or absence of the posterior capsule in the study
eye.
8. Any significant retinal disease other than neovascular AMD such as diabetic
retinopathy, retinal vascular occlusion etc.
9. Uncontrolled glaucoma (defined as intraocular pressure of 25 mmHg or more despite
treatment with antiglaucoma medications) or history of glaucoma filtering surgery in
the study eye
10. Intraocular surgery (including cataract surgery) within 2 months in the study eye prior
to enrolment
11. Any concurrent intraocular condition in the study eye that, in the opinion of the
investigator, could either require medical or surgical intervention during the study
period, or that can compromise the visual acuity of the study eye such as amblyopia
and anterior ischemic optic neuropathy
12. Presence of/history of idiopathic or autoimmune-associated uveitis in either eye.
13. Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
14. Patients with controlled or uncontrolled diabetes mellitus.
15. Patients receiving anticoagulant therapy.
16. PT and aPTT > 1.5 times of ULN
17. Patients who are HIV, HBsAg, HCV test positive.
18. Pregnancy or lactation.
19. Prior use of study medication bevacizumab
20. Use of any other anti-VEGF agents within 3 months or 5 half-lives whichever is longer
21. Hypersensitivity to study drug or any of the excipients in study medication, or history
of allergy to fluorescein.
22. Participation in any clinical study of an investigational product within previous 3
months.
23. Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic,
hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral
disease that renders the patient incapable of participating in the study.
24. History of other disease, active systemic infection, metabolic dysfunction, physical
examination finding, or clinical laboratory finding giving reasonable suspicion of a
disease or condition that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the subject at high risk
for treatment complications.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of ocular adverse eventsTimepoint: Day 7
- Secondary Outcome Measures
Name Time Method Incidence of ocular adverse events at day 28Incidence of non-ocular adverse eventsTimepoint: Day 7 & day 28