Low-Dose Ranıbızumab Admınıstratıon in Retınopathy of Prematurıty

Author(s):  
Levent Tök ◽  
Lütfi Seyrek ◽  
Özlem Tök

Abstract Purpose: To evaluate the efficiency of low dose intravitreal ranibizumab therapy in the treatment of aggressive posterior premature retinopathy (APROP).Methods: A total of 124 eyes of 62 patients who underwent intravitreal ranibizumab with APROP diagnosis between January 2015-January 2021 were evaluated retrospectively. After receiving family-approved informed consent, low-dose intravitreal ranibizumab was administered and regular follow-ups were performed.Results: Patients included in the study had a mean birth week of 26.6 (23-33 weeks), a mean birth weight of 905 (450-1970) grams, an average injection week post-natal 9.1 (4-19) weeks. The mean follow-up period was 63 (24-250) weeks. In all eyes, it was observed that ROP was regressed in the first week control after injection and no asymmetrical response was observed in the eyes of any baby. A 58 eyes recovered with a single dose of intravitreal injection therapy and peripheral retinal vascularization was completed. A second injection was required in 38 eyes. Rescue treatment was applied in addition to intravitreal ranibizumab treatment in 22 eyes of 11 babies. None of the patients had any ocular or systemic side effects.Conclusıon: Low-dose intravitreal ranibizumab injection with close follow-up and appropriate timing is an effective treatment modality in APROP. Even in patients undergoing rescue laser treatment, the treatment can be completed with a wider visual field.

PEDIATRICS ◽  
1996 ◽  
Vol 98 (4) ◽  
pp. 714-718 ◽  
Author(s):  
Laura R. Ment ◽  
Betty Vohr ◽  
William Oh ◽  
David T. Scott ◽  
Walter C. Allan ◽  
...  

Objectives. Low-dose indomethacin has been shown to prevent intraventricular hemorrhage (IVH) in very low birth weight neonates, and long-term neurodevelomental follow-up data are needed to validate this intervention. We hypothesized that the early administration of low-dose indomethacin would not be associated with adverse cognitive outcome at 36 months' corrected age (CA). Methods. We enrolled 431 neonates of 600 to 1250 g birth weight with no IVH at 6 to 12 hours in a randomized, prospective trial to determine whether low-dose indomethacin would prevent IVH. A priori, neurodevelopmental follow-up examinations, including the Stanford-Binet Intelligence Scale and Peabody Picture Vocabulary Test-Revised, and standard neurologic examinations were planned at 36 months' CA. Results. Three hundred eighty-four of the 431 infants survived (192 [92%] of 209 infants receiving indomethacin versus 192 [86%] of 222 infants receiving saline), and 343 (89%) children were examined at 36 months' CA. Thirteen (8%) of the 166 infants who received indomethacin and 14 (8%) of 167 infants receiving the placebo were found to have cerebral palsy. There were no differences in the incidence of deafness or blindness between the two groups. For the 248 English-monolingual children for whom IQ data follow, the mean gestational age was significantly younger for the infants who received indomethacin than for those who received the placebo. None of the 115 infants who received indomethacin was found to have ventriculomegaly on cranial ultrasound at term, compared with 5 of 110 infants who received the placebo. The mean ± SD Stanford-Binet IQ score for the 126 English-monolingual children who had received indomethacin was 89.6 ± 18.92, compared with 85.0 ± 20.79 for the 122 English-monolingual children who had received the placebo. Although maternal education was strongly correlated with Stanford-Binet IQ at 36 months' CA, there was no difference in educational levels between mothers of the infants receiving indomethacin and the placebo. Conclusions. Indomethacin administered at 6 to 12 hours as prophylaxis against IVH in very low birth weight infants does not result in adverse cognitive or motor outcomes at 36 months' CA.


2005 ◽  
Vol 152 (3) ◽  
pp. 411-418 ◽  
Author(s):  
Riikka Leminen ◽  
Taneli Raivio ◽  
Sirpa Ranta ◽  
Joachim Oehler ◽  
Helena von Hertzen ◽  
...  

Objective: Low dose mifepristone (RU486) is highly effective in emergency post-coital contraception (EC), although the mechanism(s) of action remains unclear. We studied the endocrine actions of 10 mg mifepristone administered orally as a single dose to eight healthy volunteers (aged 20–45 years) during the late follicular phase. Methods: Serum levels of LH, FSH, oestradiol, progesterone, leptin, mifepristone, cortisol, and gluco-corticoid bioactivity (GBA) were measured before and 1, 2, 4 and 8 h after ingestion of mifepristone on cycle day 10 or 11 (study day 1), and follow-up was continued for 10 days. Ovarian ultrasonography was performed on study days 1 and 7. Similar measurements were carried out during a control cycle. Results: Mifepristone postponed ovulation, as evidenced by a 3.4±1.1 day (means±s.d.) delay (P < 0.005) in the LH surge and 3.6±4.0 day prolongation of the treatment cycle (P = 0.08). During the mifepristone cycle, an LH surge was displayed by five subjects when serum mifepristone levels had declined to 9.5±7.1 nmol/l. During the day of mifepristone administration, circulating GBA (P < 0.001) and leptin (P < 0.001) levels declined. On the day after mifepristone administration, mean serum FSH and leptin levels were lower than pretreatment values (3.8±1.8 IU/l vs 5.2±1.1 IU/l, n = 7, P < 0.05; 28.9±6.7 μg/l vs 33.2±9.0 μg/l, n = 7, P < 0.05 respectively), and the corresponding difference in the mean serum oestradiol concentration was borderline (452±252 pmol/l vs 647±406 pmol/l, n = 7, P = 0.056). In contrast to the control cycle, individual leptin levels declined during the follow-up after ingestion of mifepristone (n = 8, P < 0.01). Conclusions: These data showed that the commonly employed dose of mifepristone for EC delays ovulation and prolongs the menstrual cycle, when given during the late follicular phase. The mechanism of action of mifepristone may include a reduction of FSH secretion via a decrease in circulating leptin.


2014 ◽  
Vol 2014 ◽  
pp. 1-5 ◽  
Author(s):  
Chuanfeng Fan ◽  
Qiang Ji ◽  
Yu Wang ◽  
Xiangwen Shu ◽  
Juan Xie

Background. To compare visual outcomes and spectral-domain optical coherence tomography results following intravitreal ranibizumab treatment for early and mid-idiopathic choroidal neovascularization (ICNV).Methods. This retrospective, case-controlled study examined 44 patients with ICNV in one eye initially treated with intravitreal ranibizumab (0.5 mg). Further intravitreal treatments were administered as necessary. Patients were divided into two groups according to disease duration, that is, ≤3 months or 3–6 months (early and mid-groups), and the data were compared.Results. All patients completed at least 12 months of follow-up. Significant differences were observed between the groups in best-corrected visual acuity and in central macular thickness (CMT) reduction at all five follow-up visits. At the last follow-up (12 months), 19 early group eyes (79.1%) and 10 mid group eyes (50.0%) had statistically significant visual gains of >15 early treatment diabetic retinopathy study (ETDRS) letters(χ2=4.130,  P=0.042). The mean number of injections was significantly higher (P=0.0001)in the mid group(2.53±1.76)than in the early group(1.22±1.01).Conclusions. Early intravitreal ranibizumab for ICNV can result in better visual prognoses, more obvious decreases in CMT, and fewer injections.


2021 ◽  
Author(s):  
Aylin Karalezli ◽  
Sema Kaderli ◽  
Ahmet Kaderli ◽  
Cansu Kaya ◽  
Sabahattin Sul

Abstract Purpose: To compare the effect of intravitreal ranibizumab (IVR) or intravitreal dexamethasone implants (IVD) on regression of hyperreflective dots (HRDs) on optical coherence tomography (OCT) B-scan in patients with branch retinal vein occlusion (BRVO). Methods: 37 eyes of 37 patients with cystoid macular edema who received IVR or IVD and followed up for at least 12 months were included in this study. The patients were divided into three groups according to intravitreal treatment. Group 1 consisted of 12 eyes who received only IVD, group 2 consisted of 10 eyes who received only IVR on a pro re nata and group 3 consisted of 15 eyes who received both IVD and IVR. OCT parameters (CMT, number of HRDs, status of external limiting membrane (ELM) and ellipsoid zone (EZ)) and best-corrected visual acuity (BCVA) were compared between the groups over the follow-up time. HRDs were categorized as HRD in inner retinal layers (from the internal limiting membrane to the inner nuclear layer) or HRD in outer retinal layers (from the outer plexiform layer to the outer border of the photoreceptor layer).Results: There was no significant difference between groups in terms of BCVA, CMT, HRDs in the inner and the outer retinal layers at baseline visit. (p˃0.05 for all) Comparing the baseline values in all groups, a significant decrease was observed in CMT in the first year. (For group 1; p=0.013, group 2; p=0.010; group 3, p<0.001) The BCVA was significantly increased after 1 year in all groups. (p=0.001, p=0.006, p<0.001) The mean number of HRDs in inner and outer retinal layers were significantly decreased in group 1 and group 3. (For group 1; p<0.001, p=0.001, for group 3; p<0.001, p<0.001) However, there was no significant difference in terms of the mean number of HRDs in inner and outer retinal layers for group 2. (p=0.134, p=0.477) At the first year, the number of HRDs in inner and outer retinal layers was significantly lower in group 1 and group 3 than group 2. (For inner HRDs; group 1 vs. group 2 p=0.007, group 2 vs. group 3 p<0.001. For outer HRDs group 1 vs. group 2 p<0.001, group 2 vs. group 3 p<0.001.) The BCVA was higher in group 3 than group 2 at 1year. (p=0.048). There was no significant difference in terms of post-treatment CMT and the number of HRDs between group 1 and group3 in posthoc tests (p=0.621, p=0.876, and p=0.632).Conclusion: The reduction in HRDs at 12 months and better BCVA after IVD intimates that the HRDs should be considered as inflammatory markers in the follow-up of CME in BRVO. Thus, IVD injection could be more appropriate for patients with higher HRDs after BRVO.


2019 ◽  
Vol 75 (4) ◽  
pp. 190-198
Author(s):  
Markéta Středová ◽  
Alexandr Stepanov ◽  
Jan Studnička ◽  
Jana Nekolová ◽  
Naďa Jirásková

Purpose: To retrospectively evaluate the efficacy and safety of ranibizumab treatment for macular edema (ME) secondary to branch retina vein occlusion (BRVO) after 24 months. Materials and Methods: This study included 39 eyes of 39 patients with ME associated with BRVO treated at the Ophthalmology Department of Faculty Hospital in Hradec Kralove. The average age of included patiens was 69,3 years, the mean duration of symptoms before treament was 5,4 months, the mean baseline visual acuity (VA) was 54,6 ETDRS (Early Treatment Diabetic Retinopathy Study) letters, the mean baseline central retinal thickness (CRT) was 544,9 μm. At 64,1% patients a retinal laserphotocoagulation was performed before intravitreal ranibizumab. After one year, the study was discontinued by 17 patiens, the remaining 22 patients were observed for 24 months. Initially, there were 3 doses of intravitreal ranibizumab administered in monthly intervals, further injections were applied according to PRN (pro re nata) regiment. Patients were examined at baseline and then at 3, 6, 9, 12 and 24 months from initiation of the treatment. In this study, the effect of ranibizumab on functional and morphological parameters of the affected eye was monitored, the safety of this treatment was also evaluated. During the follow-up, a statistically significant improvement in VA was achieved in every visit in comparison to baseline parameters, the mean VA gain at the 3 month visit was 12,1 ETDRS letters (p < 0,001), at 6 months 12,5 letters (p < 0,001), at 9 months 10,5 letters (p < 0,001), at 12 months 12,5 (p < 0,001), at 24 months 8,6 letters (p < 0,05). There was a statistically significant decrease in CRT as well in the 3, 6, 9, 12 and 24 months visits, namely 249,0 μm (p < 0,001), 185,2 μm (p < 0,001), 187,0 μm (p < 0,001), 214,8 μm (p < 0,001) and 205,2 μm (p < 0,001). The average number of doses administered to a patient was 4,9 within 12 months and 7,1 within 24 months. The treatment had greater effect in younger patients with shorter duration of symptoms and baseline VA of less than 55 ETDRS letters (6/24 or worse. Nor serious, neighter long-term adverse events occured, only occasional intraocular pressure elevation after intravitreal application was found. Conclusion: Our results from common clinical practice are consistent with the results of large clinial trials, we confirmed particularly good treatment efficacy in younger patients with shorter duration of macular edema and poorer baseline visual acuity. The safety of ranibizumab treatment was confirmed.


2015 ◽  
Vol 234 (1) ◽  
pp. 33-39 ◽  
Author(s):  
Wataru Matsumiya ◽  
Shigeru Honda ◽  
Keiko Otsuka ◽  
Akiko Miki ◽  
Takayuki Nagai ◽  
...  

Purpose: To compare the response to ranibizumab between patients with typical neovascular age-related macular degeneration (tAMD) and those with polypoidal choroidal vasculopathy (PCV), and to determine the predictors for the outcomes. Methods: Fifty-nine eyes from 59 consecutive patients (tAMD: 27 eyes, PCV: 32 eyes) were treated with three monthly ranibizumab injections followed by as-needed retreatment. Best-corrected visual acuity (BCVA) and morphological parameters were evaluated over 24 months of follow-up. Results: The mean BCVA in tAMD and PCV patients was significantly improved at 3 months (-0.22 and -0.09 logMAR units, respectively). The improvement in BCVA was sustained up to 24 months in tAMD (p = 0.01) but not in PCV patients. The significant predictor for good response to ranibizumab in tAMD patients was the improvement of BCVA at 3 months, whereas that in PCV patients was the anatomical resolution at 3 months. Conclusions: Ranibizumab is an effective therapy for tAMD and PCV over 24 months. The predictors for good outcome might be different between tAMD and PCV.


2021 ◽  
pp. 112067212110483
Author(s):  
Selma Özbek-Uzman ◽  
Züleyha Yalnız-Akkaya ◽  
Evin Şingar Özdemir ◽  
Ayşe Burcu

Purpose: We aimed to investigate the efficacy and safety of single-dose autologous serum eye drops (ASEDs) for treatment of persistent corneal epithelial defects (PEDs). Methods: About 34 eyes of 26 patients treated from March 2016 to May 2020 with a single dose of ASEDs for PEDs that did not respond to conventional treatment were retrospectively evaluated. Patient demographics, predisposing factors, size, and duration of the PED, duration of treatment, and dosage of ASEDs, PED healing time, success rate of the ASED treatment, and follow-up time after the onset of ASED treatment were recorded. Autologous serum eye drops (20%) were prepared by diluting the serum with preservative-free artificial tears in single-dose vials. Vials were stored at −20°C and used daily after dissolving. Results: The mean patient age was 47.0 ± 18.5 years, and 13 (50%) of the patients were male. The most common indication for ASEDs was PED after keratoplasty. The mean duration of ASED treatment was 8.5 ± 6.3 months, and mean follow-up time was 22.8 ± 12.2 months. Autologous serum eye drop treatment was effective in 25 (73.5%) eyes and partially effective in 5 (14.7%) eyes. None of the eyes displayed complications related to the treatment. Conclusion: In patients with PED for whom conservative treatment is insufficient, ASEDs prepared by dilution with preservative-free artificial tears in single-dose vials and administered based on the daily use principle appear to be effective and safe.


2021 ◽  
Author(s):  
fatma esin özdemir ◽  
selin Üstün Bezgin ◽  
Zeliha Karademir

Abstract OBJECTIVE: An investigation of incidences of nasal septal deviation (NSD) and its effect on surgical success in patients with congenital nasolacrimal dacryostenosis (CNLDO).METHODS: A retrospective review was made of the medical records of patients who presented to the ophthalmology clinic due to epiphora, were diagnosed with CNLDO and underwent probing. The diagnosis was established by history, clinical examination, and fluorescein disappearance test (FDT)1. Patients with FDT grade 2 and 3 underwent surgery. Success was defined as postoperative FDT grade 0–1. The patients were assessed in terms of gestational week, birth weight, type of delivery, nasal endoscopic examination findings (presence of NSD), time of surgery, treatments received, recurrence and complications.RESULTS: The study comprised 72 eyes of 58 patients who were diagnosed with CNLDO and underwent surgical treatment. Of the patients, 44 (75.86%) had unilateral, and 14 (24.14%) had bilateral CNLDO; 41 (56.94%) were female and 31 (43.06%) were male. The mean gestational age at birth was 38.01 weeks (32–41 weeks), the mean birth weight was 3321.25 (2020–4500 g), the number of cases delivered by cesarean section was 40 (55.56%), and 32 (44.44%) were vaginal deliveries. There were 13 (18.06%) patients with detected NSD after endonasal examination and 59 (81.94%) patients with normal endonasal examination in the Otorhinolaryngology (ORL) department. The time of surgery was 10 –34 months (mean: 19.06 months, SD: 5.73), the length of follow-up was 6–16 months (mean: 9.90 months, SD: 2.58). The rate of probing success was 80.6% (58 eyes), and there was recurrence in 19.4% (14 eyes).The success rate of the probing did not statistically significantly differ by gender (p=0.323), the mean birth week (p=0.123), the mean birth weight (p=0.186), the involved eye (p=0.891), the type of delivery (p=0.891), the mean length of follow-up (months) (p=0.701), the mean month of surgery (p=0.607), and the side of NSD (p=0.853). The incidence of NSD was statistically significantly higher in the group in which the probing failed, than in the group in which the probing was successful (p=0.004).CONCLUSION: NSD was identified in 18% of the patients who were diagnosed with CNLDO and underwent surgery. The incidence of NSD was significantly higher in the group where the probing procedure failed. Pre-treatment nasal endoscopy is important for the treatment planning and prognosis of CNLDO patients.


2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Aliya Aziz Khan ◽  
Hajar Abu Alrob ◽  
Iman M’Hiri ◽  
Hosay Said ◽  
Sharjil Hussain ◽  
...  

Abstract Introduction: Denosumab, a fully human monoclonal antibody to RANK-ligand, has been shown to increase bone mineral density (BMD) and reduce the risk of hip, vertebral and non-vertebral fractures in postmenopausal women with osteoporosis (1-3). Varying doses of denosumab including 30mg/3months have demonstrated a decrease in bone remodelling in a dose-dependent manner (2,4-6). The primary objective of this study is to evaluate the efficacy of low dose denosumab (30mg/6 months) in postmenopausal women with osteoporosis who are reluctant to consider or continue the full dose of denosumab due to adverse events (AE) or concerns of potential AE. Methods: Following informed consent, postmenopausal women with a T-score of ≤ -2.5 at the lumbar spine (LS) or at the total hip (TH) received denosumab 30mg/6months. Patients with an additional skeletal disorder, prior fragility fracture, or on oral steroids (daily in the past 12 months) were excluded. The primary endpoint was the percent change in BMD at the lumbar spine (LS), total hip (HP), femoral neck (FN) and 1/3 radius (1/3R) at 12 months. Secondary outcomes were 1) percent change in BMD at the LS, TH, FN, and 1/3R at 24 months and 2) AE. Results: We enrolled 183 patients. The mean age was 69 years (SD= 7.07), 80% of patients had a moderate fracture risk (CAROC tool), 3% were current smokers and 9% consumed alcohol daily. 14.4% of patients were on SSRI/SNRI, 9.6% were on PPI, and no patient was on an aromatase inhibitor. At 12 months (n=125), the mean BMD significantly increased by +2.0% (95% CI 2.8%-1.3%) at the LS (p&lt;0.001). There was no significant change in BMD at the FN, TH, AND 1/3R. At 24 months (n=65), the percent change in BMD was +3.4% (95% CI 4.8%-2.0%: p&lt;0.001) at the LS, +1.5% (95% CI 2.9%-0.15%: p=0.031) at the FN, +1.9% (95% CI 3.5%-0.24%: p=0.025) at the 1/3R. There was no significant change in BMD at the TH. Conclusion: Low dose denosumab appears to be effective in maintaining BMD in postmenopausal women with a moderate fracture risk and may be of benefit in individuals who are experiencing side effects or concerns of side effects. This may also be of value following 10 years of therapy in order to maintain BMD. References 1.Bekker, PJ, Holloway DL, Rasmussen AS, Murphy R, Martin SW, Leese PT... Depaoli AM. A Single-Dose Placebo-Controlled Study of AMG 162, a Fully Human Monoclonal Antibody to RANKL, in Postmenopausal Women. JBMR, 2004;19(7), 1059-1066. 2.Kumagai Y, Hasunuma T, Padhi D. A randomized, double-blind, placebo-controlled, single-dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of denosumab administered subcutaneously to postmenopausal Japanese women. Bone, 2011;49(5), 1101-1107. 3.Lewiecki EM, Miller PD, Mcclung MR, Cohen SB, Bolognese MA, Liu Y, . . . Fitzpatrick LA. Two-Year Treatment With Denosumab (AMG 162) in a Randomized Phase 2 Study of Postmenopausal Women With Low BMD. JBMR, 2007;22(12), 1832-1841.


2014 ◽  
Vol 5 (3) ◽  
pp. 189-196 ◽  
Author(s):  
P. Khandelwal ◽  
V. Jain ◽  
A. K. Gupta ◽  
M. Kalaivani ◽  
V. K. Paul

Growth acceleration or catch-up growth (CUG) in early infancy is a plausible risk factor for later obesity and cardiovascular disease. We postulate that this risk may be mediated by an adverse programming of body composition by CUG in early infancy. The study was aimed at evaluating the association between the pattern of gain in weight and length of term low birth weight (LBW) infants from birth to 6 months, with fat mass percent (FM%) at 6 months. Term healthy singleton LBW infants were enrolled. Baby’s weight and length z-scores were measured at birth and three follow-up visits. Body composition was measured by dual-energy absorptiometry at last visit. A total of 54 babies (28 boys) were enrolled. The mean birth weight and gestation were 2175±180 g and 37.6±0.6 weeks. Follow-up visits were at 1.4±0.0, 3.0±0.3 and 7.2±0.8 months. The proportion of babies who showed CUG [increase in weight for age z-score (∆WAZ)>0.67] from birth to 1.4, 3.0 and 7.2 months was 29.6, 26.4 and 48.5%, respectively. The mean FM% at 7.2 months was 16.6±7.8%. Infants with greater ∆WAZ from birth to 3 and 7.2 months had significantly greater FM% at 7.2 months after adjusting for current age, size and gender. Infants with early CUG (<1.4 months) had higher FM% than infants with no CUG. We conclude that earlier and greater increment in WAZ is positively associated with FM%.


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